Reported May 27, 2020 · Terminated
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp.,…
West-Ward Columbus Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: West-Ward Columbus Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr
- byWest-Ward Pharmaceuticals Corp., Eatontown, NJ 07724
- NDC0054-0415-25
- Lot codes and dates
Lot #: AA4424AExp. 07/31/2020
- Amount recalled
- 3336 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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