Recalls / Class III
Class IIID-1282-2020
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.
- Affected lot / code info
- Lot #: AA4424A, Exp. 07/31/2020
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Recalling firm
- Firm
- West-Ward Columbus Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 3336 Bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2020-05-13
- FDA classified
- 2020-05-29
- Posted by FDA
- 2020-05-27
- Terminated
- 2022-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1282-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.