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.