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Recall Observatory FDA recall evidence

Drug product

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

D-0476-2017

January 30, 2017

Class II

Product summary

Firm
Actavis Inc
Event
Event 76406
Status
Terminated
Classification
Class II
Quantity
499320 units
Official record key
drug-enforcement:D-0476-2017

Official wording

Reason: Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Code information: Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/17; 3136782, Exp. 09/30/17; 3136903, 3136904, Exp.10/31/17; 3138250, Exp. 07/31/17; 3138968, Exp. 08/31/17; 3140000, Exp. 09/30/17

Distribution pattern: Nationwide in US

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification