FDA recall D-0521-2020

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.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2019-11-11

Report date

2019-12-04

Termination date

2021-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0521-2020