AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by Au
Recalled December 4, 2019 · FDA recall D-0521-2020 · AuroMedics Pharma
Hazard
Crystallization: Presence of visible particulate matter. · FDA Class III
Units
29,830 vials
Sold at
Distributed Nationwide in the US
Description
Crystallization: Presence of visible particulate matter.
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
Manufacturer(s)
AuroMedics Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →