Class II
Terminated
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
- Company
- Apotex Inc.
- Recall Initiated
- August 17, 2015
- Posted
- September 23, 2015
- Recall Number
- D-1814-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 117,644 Bottles
- Firm Location
- Toronto, Canada
Reason for Recall
Failed Stability Specifications: product may not meet specification limit for assay test.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
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
More recalls by Apotex Inc.
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario...
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Oct 21, 2015 · Class II
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Jul 15, 2015 · Class II
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