Recall: D-0521-2020

Class III - Minor Violations

Class IIIClassification

2019-11-11Initiated

TerminatedStatus

AuroMedics Pharma LLCFirm

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

Crystallization: Presence of visible particulate matter.

Distribution

Distributed Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.