FDA-Drug2020-02-19Class II

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.

Hazard

cGMP Deviations

Sold states
Nationwide in the U.S.
Affected count
2207 Vials
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0834-2020

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