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
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
Failed Stability Specifications