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Recall Observatory FDA recall evidence

Drug product

Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.

D-0992-2022

May 11, 2022

Class I

Product summary

Firm
Teva Pharmaceuticals USA Inc
Event
Event 90182
Status
Terminated
Classification
Class I
Quantity
4224 cartons
Official record key
drug-enforcement:D-0992-2022

Official wording

Reason: Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

Code information: Lot # GD01090, Exp 05/2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-Of-Specification