D-1282-2020 Class III Terminated
FDA drug recall D-1282-2020 was initiated by West-Ward Columbus Inc on May 13, 2020 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants. The recall status is terminated (terminated October 2, 2022). Affected quantity: 3336 Bottles.
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