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Recall Observatory FDA recall evidence

Drug 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 E-flute cartons.

D-0912-2018

June 19, 2018

Class III

Product summary

Firm
Wockhardt Limited
Event
Event 80356
Status
Terminated
Classification
Class III
Quantity
31,710 tablets
Official record key
drug-enforcement:D-0912-2018

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: 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).

Distribution pattern: Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications