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Recall Enforment Report D-0521-2020

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by AuroMedics Pharma LLC, originally initiated on 11-11-2019 for the product Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09 The product was recalled due to crystallization: presence of visible particulate matter.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0521-202011-11-201912-04-2019Class III29,830 vialsAmiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09Crystallization: Presence of visible particulate matter.Terminated
D-0520-202011-11-201912-04-2019Class III28,810 vialsAmiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03Crystallization: Presence of visible particulate matter.Terminated
D-0522-202011-11-201912-04-2019Class III138,720 vialsAmiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18Crystallization: Presence of visible particulate matter.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
55150-180Amiodarone Hydrochloride Amiodarone HydrochlorideInjection, SolutionIntravenousAuromedics Pharma LlcHuman Prescription Drug
55150-181Amiodarone Hydrochloride Amiodarone HydrochlorideInjection, SolutionIntravenousAuromedics Pharma LlcHuman Prescription Drug
55150-182Amiodarone Hydrochloride Amiodarone HydrochlorideInjection, SolutionIntravenousAuromedics Pharma LlcHuman Prescription Drug