fda
291 records
FDA Drug Recall: succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD S
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For I
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, Fo
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, Ph
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 1
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag,
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL sy
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, P
2020-04-15
Class II — Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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FDA Drug Recall: NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg
2020-01-01
Class III — Subpotent Drug
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FDA Drug Recall: NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg
2020-01-01
Class III — Subpotent Drug
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FDA Drug Recall: NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg
2020-01-01
Class III — Subpotent Drug
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FDA Drug Recall: Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe
2019-07-10
Class I — Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains s...
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FDA Drug Recall: 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3
2019-01-16
Class II — Subpotent
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FDA Drug Recall: Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in S
2018-12-26
Class II — Sub-potent
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FDA Drug Recall: Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in So
2018-12-26
Class II — Sub-potent
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FDA Drug Recall: 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Serv
2018-08-15
Class II — CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
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FDA Drug Recall: 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5
2018-08-15
Class II — CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
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FDA Drug Recall: 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in
2018-08-15
Class II — CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
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FDA Drug Recall: HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3
2018-06-20
Class II — Superpotent and Subpotent
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FDA Drug Recall: Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 uni
2018-04-25
Class III — cGMP deviations
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FDA Drug Recall: Glycopyrrolate in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all p
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Labetalol HCl in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packag
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, a
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packagi
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, a
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pac
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Succinylcholine Chloride in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packa
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pac
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packa
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all pa
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Adenosine Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all p
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Rocuronium Bromide in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all pa
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packa
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all p
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, a
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Atropine Sulfate Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packa
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Ketamine HCl Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Esmolol HCl in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Neostigmine Methylsulfate Injection in all strengths, all doses, and all packagi
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Lidocaine HCl in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses,
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pack
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Methadone HCl Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Midazolam HCl Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Nicardipine HCl in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, a
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
2018-02-28
Class II — Lack of sterility assurance.
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FDA Drug Recall: 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 m
2018-02-21
Class II — Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endot...
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FDA Drug Recall: 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx
2018-02-21
Class II — Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endot...
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FDA Drug Recall: 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, R
2018-02-21
Class II — Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endot...
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FDA Drug Recall: Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syr
2018-01-24
Class II — Superpotent Drug
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FDA Drug Recall: ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL
2018-01-24
Class II — Subpotent Drug
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FDA Drug Recall: morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
2018-01-03
Class III — Labeling: Incorrect or Missing Lot and/or Exp. Date
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FDA Drug Recall: morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
2018-01-03
Class III — Labeling: Incorrect or Missing Lot and/or Exp. Date
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FDA Drug Recall: HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per
2018-01-03
Class III — Labeling: Incorrect or Missing Lot and/or Exp. Date
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FDA Drug Recall: Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged
2017-11-22
Class II — Superpotent drug: out of specification result for potency
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FDA Drug Recall: Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only,
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only,
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL ba
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL ba
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only,
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL ba
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL ba
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL ba
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, C
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag,
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only
2017-11-01
Class II — Subpotent Drug
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FDA Drug Recall: Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL
2017-09-27
Class II — Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
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FDA Drug Recall: Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL
2017-09-27
Class II — Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
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FDA Drug Recall: Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 1
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 m
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 m
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 1
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intra
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intrav
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 15
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 2
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 m
2017-07-26
Class II — Lack of Assurance of Sterility; media fill failure at manufacturer
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FDA Drug Recall: Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride
2017-07-12
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
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FDA Drug Recall: Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride
2017-07-12
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
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FDA Drug Recall: Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride
2017-07-12
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
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FDA Drug Recall: Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride
2017-07-12
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
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FDA Drug Recall: Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlorid
2017-07-12
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
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FDA Drug Recall: Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlorid
2017-07-12
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
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FDA Drug Recall: Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chl
2017-07-12
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date
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FDA Drug Recall: Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Co
2017-06-21
Class III — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, ND
2017-06-21
Class II — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service
2017-06-21
Class III — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code
2017-06-21
Class II — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code
2017-06-21
Class III — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service C
2017-06-21
Class III — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code
2017-06-21
Class III — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, N
2017-06-21
Class II — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service C
2017-06-21
Class III — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2
2017-06-21
Class II — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service C
2017-06-21
Class III — Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
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FDA Drug Recall: Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL
2017-03-22
Class III — Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
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FDA Drug Recall: Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only,
2016-11-09
Class II — Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
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FDA Drug Recall: morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preserva
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a s
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product cod
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL To
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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FDA Drug Recall: succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Vo
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syri
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe,
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, Phar
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syrin
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 m
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preserva
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Con
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syring
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chl
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a sy
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Pres
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, Phar
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, Phar
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Pre
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Pre
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a s
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL To
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preserv
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syr
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL T
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a sy
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syri
2016-10-19
Class II — Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total
2016-10-19
Class II — Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a sy
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preser
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total V
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syrin
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1
2016-10-19
Class I — Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume
2016-10-19
Class II — Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, Fo
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume i
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Vol
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe,
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Pre
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preserva
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syri
2016-10-19
Class II — Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 m
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL T
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume
2016-10-19
Class II — Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% S
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 1
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% S
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Cod
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% S
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% S
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Cod
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% S
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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FDA Drug Recall: 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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FDA Drug Recall: 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% S
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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FDA Drug Recall: 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL H
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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FDA Drug Recall: 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medic
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9%
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 10
2016-07-27
Class II — Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
View Source
FDA Drug Recall: Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium
2016-06-15
Class II — Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
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FDA Drug Recall: NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride
2016-03-23
Class III — Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
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FDA Drug Recall: NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride
2016-03-23
Class III — Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
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FDA Drug Recall: fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1
2016-02-24
Class I — Subpotent Drug
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FDA Drug Recall: fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL
2016-02-24
Class I — Subpotent Drug
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FDA Drug Recall: Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Mo
2016-02-17
Class I — Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
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FDA Drug Recall: PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
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FDA Drug Recall: PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
View Source
FDA Drug Recall: PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
View Source
FDA Drug Recall: Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
View Source
FDA Drug Recall: PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
View Source
FDA Drug Recall: PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
View Source
FDA Drug Recall: Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
View Source
FDA Drug Recall: Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250
2015-09-30
Class I — Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (h...
View Source
FDA Drug Recall: Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flo
2015-09-16
Class II — Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
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FDA Drug Recall: HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injec
2015-09-02
Class I — Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to...
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FDA Drug Recall: EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg
2015-09-02
Class I — Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to...
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FDA Drug Recall: EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg
2015-09-02
Class I — Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to...
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FDA Drug Recall: oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL
2015-09-02
Class I — Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to...
View Source
FDA Drug Recall: EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg p
2015-09-02
Class I — Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to...
View Source
FDA Drug Recall: HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Inject
2015-09-02
Class I — Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to...
View Source
nppes
1 records
ny_corps
1 records
NY Corp: PHARMEDIUM SERVICES, LLC
2014-08-12
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Delaware
View Source
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