Drug 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.
D-1282-2020
Product summary
- Event
- Event 85709
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3336 Bottles
- Official record key
drug-enforcement:D-1282-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Code information: Lot #: AA4424A, Exp. 07/31/2020
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of Specification