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.

Recall Number: D-1282-2020

Firm: West-Ward Columbus Inc

Classification: Class III

Status: Terminated

Report Date: 20200527

Initiation Date: 20200513

Termination Date: 20221002

Reason for Recall

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

Product Description

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.