American Regent, Inc. recalls
4 recalls on record · FDA
Every recall we have on record for American Regent, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
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Health Serious
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose…
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc. May 7, 2025
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Health Serious
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL…
Presence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc. Dec 11, 2024
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Health Serious
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL…
Presence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc. Dec 11, 2024
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Health Serious
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose…
Subpotent product in addition to having out-of-specification results for impurities.
American Regent, Inc. May 29, 2024
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