US Drug Recall Register
Class III · Low risk Terminated Initiated May 13, 2020 (6 years ago)

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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.

Recalling firm
West-Ward Columbus Inc
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1282-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.