Ethacrynate Sodium for Injection recalled over manufacturing violations
- Recall date
- January 31, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Zydus Pharmaceuticals USA Inc recalls Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited…
- Recall number
- D-0834-2020
- FDA classification
- Class II
- Brand / firm
- Zydus Pharmaceuticals USA Inc
- Sold / distributed
- Nationwide in the U.S.
Why it was recalled
cGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
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