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

Recall Number: D-0521-2020

Firm: AuroMedics Pharma LLC

Classification: Class III

Status: Terminated

Report Date: 20191204

Initiation Date: 20191111

Termination Date: 20210401

Crystallization: Presence of visible particulate matter.

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