fda
37 records
FDA Drug Recall: R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamin
2025-11-05
Class II — Presence of Particulate Matter
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FDA Drug Recall: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100
2025-04-02
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 m
2025-04-02
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 m
2025-04-02
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injectio
2022-10-05
Class III — Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
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FDA Drug Recall: R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride sol
2020-07-01
Class III — Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
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FDA Drug Recall: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection
2020-06-17
Class II — Subpotent drug - Product did not contain drug.
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FDA Drug Recall: fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preser
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA P
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharm
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservat
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.66
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preserv
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free,
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Ph
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preserva
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preserv
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL)
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA P
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.6
2019-12-11
Class II — Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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FDA Drug Recall: Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL B
2018-12-19
Class III — Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
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FDA Drug Recall: Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Fre
2018-09-26
Class I — Subpotent Drug: Product may not have the active ingredient present in the bag.
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FDA Drug Recall: PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, pa
2016-07-13
Class I — Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective ov...
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lobbying
3 records
Lobbying Client: QUVA PHARMA, INC.
Lobbied by VAN SCOYOC ASSOCIATES — 503B outsourcing facility
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Lobbying Client: QUVA PHARMA, INC.
Lobbied by PRIME POLICY GROUP — 503B outsourcing facility
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Lobbying Client: QUVA PHARMA, INC.
Lobbied by VAN SCOYOC ASSOCIATES — 503B outsourcing facility
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ny_corps
1 records
NY Corp: QUVA PHARMA, INC.
2015-08-20
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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