FDA recall D-0834-2020

Product

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.

Reason for recall

cGMP Deviations

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-01-31

Report date

2020-02-19

Termination date

2021-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

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