fda
166 records
FDA Drug Recall: PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentrati
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, R
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Inj
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration =
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentratio
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fi
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fi
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml)
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/m
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL In
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentratio
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CAD
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentratio
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration =
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL),
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL I
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentrati
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL I
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration =
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration =
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL I
2024-04-03
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag
2023-08-02
Class II — cGMP deviations: due to shipment of rejected units.
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FDA Drug Recall: Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Con
2023-05-03
Class III — Subpotent Drug: Out of specification results for low potency was obtained.
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FDA Drug Recall: Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration =
2023-03-08
Class III — Subpotent Drug
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FDA Drug Recall: Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmace
2022-05-11
Class II — CGMP Deviations
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FDA Drug Recall: Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceutic
2022-05-11
Class II — CGMP Deviations
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FDA Drug Recall: Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx
2022-05-11
Class II — CGMP Deviations
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FDA Drug Recall: HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dos
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dos
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx O
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Ph
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Phar
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII,
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, R
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syring
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Phar
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuti
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only,
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pha
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 m
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml S
2021-01-13
Class III — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx On
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Ph
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose S
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcod
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only,
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5
2021-01-13
Class II — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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FDA Drug Recall: Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose C
2020-12-30
Class II — Subpotent drug.
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FDA Drug Recall: Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals
2020-12-23
Class III — Subpotency: Out-of-specification stability test result for low potency was obtained.
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FDA Drug Recall: Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Contain
2020-09-02
Class I — Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any...
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FDA Drug Recall: Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container
2020-09-02
Class I — Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any...
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FDA Drug Recall: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Containe
2020-09-02
Class I — Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any...
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FDA Drug Recall: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container
2020-09-02
Class I — Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any...
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FDA Drug Recall: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx
2020-08-19
Class II — Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
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FDA Drug Recall: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx
2020-06-24
Class II — Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
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FDA Drug Recall: Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Wi
2019-12-18
Class II — Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
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FDA Drug Recall: Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentr
2019-08-28
Class II — Lack of Assurance of Sterility.
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FDA Drug Recall: Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single
2018-09-19
Class I — Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
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FDA Drug Recall: Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use
2018-07-18
Class II — Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
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FDA Drug Recall: Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, S
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 12
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Phar
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pha
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syring
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmace
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, S
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag,
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pha
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pha
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Phar
2018-07-11
Class II — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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FDA Drug Recall: labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use,
2018-03-14
Class III — Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 an...
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FDA Drug Recall: Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe,
2018-01-17
Class II — Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
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FDA Drug Recall: fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 m
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuti
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcin
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL
2017-11-08
Class II — Lack Of Assurance Of Sterility.
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FDA Drug Recall: PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuti
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuti
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only,
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceutica
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceutical
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Singl
2017-08-02
Class II — Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
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FDA Drug Recall: fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (To
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (To
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Do
2017-08-02
Class II — Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
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FDA Drug Recall: ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115
2017-08-02
Class II — Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
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FDA Drug Recall: fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx onl
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceutic
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmace
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Vo
2017-08-02
Class II — Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
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FDA Drug Recall: PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, R
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 m
2017-08-02
Class II — Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
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FDA Drug Recall: ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuti
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Phar
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preser
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pha
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pha
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only,
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Phar
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx on
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuti
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceut
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SC
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceutica
2017-08-02
Class II — Lack of Assurance of Sterility; product has the potential to leak.
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FDA Drug Recall: PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg p
2017-08-02
Class II — Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
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FDA Drug Recall: Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Tot
2017-07-19
Class II — Lack of sterility assurance
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FDA Drug Recall: Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+)
2017-07-19
Class II — Lack of sterility assurance
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FDA Drug Recall: Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Tot
2017-07-19
Class II — Lack of sterility assurance
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FDA Drug Recall: Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+)
2017-07-19
Class II — Lack of sterility assurance
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FDA Drug Recall: ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total App
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volum
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 1
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Vo
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total App
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Vo
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 1
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total App
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Si
2017-06-07
Class II — Lack of assurance of sterility: Product bags leaking at seam.
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FDA Drug Recall: Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx O
2017-04-12
Class I — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
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FDA Drug Recall: Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only,
2017-04-12
Class I — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
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FDA Drug Recall: Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx
2017-04-12
Class I — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
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FDA Drug Recall: Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA
2017-04-12
Class I — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
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FDA Drug Recall: Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx
2017-04-12
Class I — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
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FDA Drug Recall: Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515
2017-04-12
Class I — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
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FDA Drug Recall: Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only,
2017-04-12
Class I — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
View Source
FDA Drug Recall: PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2
2015-06-17
Class II — Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
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FDA Drug Recall: Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe,
2015-04-29
Class II — Presence of particulate.
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FDA Drug Recall: Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe,
2015-01-21
Class II — Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
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nppes
1 records
ny_corps
1 records
NY Corp: SCA PHARMACEUTICALS, LLC
2015-10-08
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Arkansas
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