fda
12 records
FDA Drug Recall: 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenou
2025-09-17
Class II — Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
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FDA Drug Recall: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Sing
2025-04-02
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL
2023-11-29
Class I — Presence of Particulate Matter: Silicone
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FDA Drug Recall: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Sing
2023-11-29
Class I — Presence of Particulate Matter: Silicone
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FDA Drug Recall: Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Singl
2023-11-29
Class I — Presence of Particulate Matter: Silicone
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FDA Drug Recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose
2022-12-21
Class I — Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
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FDA Drug Recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose
2022-12-21
Class I — Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
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FDA Drug Recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose
2022-11-02
Class I — Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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FDA Drug Recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose
2022-11-02
Class I — Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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FDA Drug Recall: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx
2022-01-19
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx o
2020-09-23
Class III — Short Fill
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FDA Drug Recall: Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count
2018-05-30
Class II — Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
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fda_adverse
2 records
FDA AE Manufacturer: EXELA PHARMA SCIENCES, LLC
Drug adverse event reporter — Product: VERAPAMIL HYDROCHLORIDE
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FDA AE Manufacturer: Exela Pharma Sciences,LLC
Drug adverse event reporter — Product: ZINC CHLORIDE
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lobbying
1 records
Lobbying Client: EXELA PHARMA SCIENCES
Lobbied by BROYDRICK & ASSOCIATES — Injectable and ophthalmic pharmaceutical products.
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