FDAClass IIIJuly 18, 2018

Enalapril Maleate Tablets USP recall: Impurity Out of Spec

Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in…

Why was Enalapril Maleate Tablets USP recalled?

Failed Impurities/Degradation Specifications

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?

Batch# DR10445 (Exp: 4/19); Batch# DR10637 (Exp: 5/19); Batch# DR10646 (Exp: 5/19); Batch# DR10647 (Exp: 5/19); Batch# DR10725 (Exp: 7/19); Batch# DR10755 (Exp: 7/19); Batch# DR10811 (Exp: 9/19); Batch# DS10040 (Exp: 12/19); Batch# DS10041 (Exp: 12/19); Batch# DS10024 (Exp: 12/19); and Batch# DS10048 (Exp: 12/19).

Product
Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in…
Recalling firm
Wockhardt Limited
Quantity
31,710 tablets
Distribution
Nationwide.
Recall date
July 18, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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