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Recall Observatory FDA recall evidence

Drug product

Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5

D-1814-2015

August 17, 2015

Class II

Product summary

Firm
Apotex Inc.
Event
Event 71999
Status
Terminated
Classification
Class II
Quantity
117,644 Bottles
Official record key
drug-enforcement:D-1814-2015

Official wording

Reason: Failed Stability Specifications: product may not meet specification limit for assay test.

Code information: Lot #s: a) KP9749, KT3501, Exp 09/2015, KP4524, Exp 11/2015, KV8264, Exp 01/2016, KX8713, KX8714, KX8715, Exp 04/2016; b) KP4525, Exp 11/2015, KP9750, Exp 12/2015, KX8716, Exp 04/2016

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Stability Specifications