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Recall Observatory FDA recall evidence

Drug product

Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.

D-0208-2018

December 14, 2017

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 78753
Status
Terminated
Classification
Class II
Quantity
4,969 bottles
Official record key
drug-enforcement:D-0208-2018

Official wording

Reason: Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.

Code information: Lot # 30229439A, Exp 12/17

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification