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.
Reported: May 27, 2020 Initiated: May 13, 2020 #D-1282-2020
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.
Details
- Recalling Firm
- West-Ward Columbus Inc
- Units Affected
- 3336 Bottles
- Distribution
- Nationwide in the US
- Location
- Columbus, OH
Frequently Asked Questions
What product 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.. Recalled by West-Ward Columbus Inc. Units affected: 3336 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 27, 2020. Severity: Low. Recall number: D-1282-2020.
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