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.

Zydus Pharmaceuticals USA Inc
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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