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American Regent

7 recalls •

• Categories: Prescription Drugs

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.

Class I - Dangerous

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Apr 18, 2025 Prescription Drugs Nationwide View Details →

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]

Class I - Dangerous

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Apr 18, 2025 Prescription Drugs Nationwide View Details →

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).

Class I - Dangerous

Presence of Particulate Matter: Potential for glass delamination from the vials.

Nov 11, 2024 Prescription Drugs Nationwide View Details →

Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).

Class I - Dangerous

Presence of Particulate Matter: Potential for glass delamination from the vials.

Nov 11, 2024 Prescription Drugs Nationwide View Details →

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).

Class I - Dangerous

Presence of Particulate Matter: Potential for glass delamination from the vials.

Nov 11, 2024 Prescription Drugs Nationwide View Details →

Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01

Class I - Dangerous

Subpotent product in addition to having out-of-specification results for impurities.

May 13, 2024 Prescription Drugs Nationwide View Details →

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10

Class I - Dangerous

Lack of Assurance of Sterility.

May 14, 2024 Prescription Drugs View Details →