FDAClass IIIMay 27, 2020

Ethacrynic Acid Tablets USP recall: Impurity Out of Spec

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC…

Why was Ethacrynic Acid Tablets USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: AA4424A, Exp. 07/31/2020

Product
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC…
Recalling firm
West-Ward Columbus Inc
Quantity
3336 Bottles
Distribution
Nationwide in the US
Recall date
May 27, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls