FDA recall D-1282-2020

Product

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.

Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-05-13

Report date

2020-05-27

Termination date

2022-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1282-2020