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Recall Observatory FDA recall evidence

Drug product

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01

D-0074-2018

August 29, 2017

Class III

Product summary

Firm
Amerisource Health Services
Event
Event 78118
Status
Terminated
Classification
Class III
Quantity
93,600 tablets
Official record key
drug-enforcement:D-0074-2018

Official wording

Reason: Failed Stability Specifications

Code information: Lot #:167194; Exp. 12/31/2018

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Stability Specifications