AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed…
- Recall date
- November 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0522-2020
- 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, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
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