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 A…
- Recall date
- November 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0521-2020
- FDA classification
- Class III
- Brand / firm
- AuroMedics Pharma LLC
- Sold / distributed
- Distributed Nationwide in the US
Why it was recalled
Crystallization: Presence of visible particulate matter.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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