FDAFDA · Food and drugs·Recall number D-1282-2020
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.
Published May 27, 2020 · Recall initiated: May 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- West-Ward Columbus Inc
- Distributor
- Nationwide in the US
- Lot
- Lot #: AA4424A, Exp. 07/31/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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