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.

FDA recall notice · announced May 27, 2020 · West-ward Columbus

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the US
Lot/code information: Lot #: AA4424A, Exp. 07/31/2020
Quantity: 3336 Bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.