FDA-Drug2020-05-27Class III

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.

West-Ward Columbus Inc
Hazard

Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.

Sold states
Nationwide in the US
Affected count
3336 Bottles
Manufactured in
1809 Wilson Rd, N/A, Columbus, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1282-2020

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