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.

FDA recall notice · announced February 19, 2020 · Zydus Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

cGMP Deviations

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020
Quantity: 2207 Vials
Status: Terminated
Products in this recall event:
- 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, (D-0834-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.