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.
Recall initiated: 20200513
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated