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
Reason for recall: Crystallization: Presence of visible particulate matter.
Recall initiated: 20191111
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated