D-1282-2020 Class III Terminated

Recalled by West-Ward Columbus Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
May 27, 2020
Initiation Date
May 13, 2020
Termination Date
October 2, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3336 Bottles

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the US

Code Information

Lot #: AA4424A, Exp. 07/31/2020