Recalls / Class II
Class IID-1814-2015
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
- Affected 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
Why it was recalled
Failed Stability Specifications: product may not meet specification limit for assay test.
Recalling firm
- Firm
- Apotex Inc.
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, Toronto, N/A, Canada
Distribution
- Quantity
- 117,644 Bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-08-17
- FDA classified
- 2015-09-15
- Posted by FDA
- 2015-09-23
- Terminated
- 2022-06-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1814-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.