D-1814-2015 Class II Terminated
FDA drug recall D-1814-2015 was initiated by Apotex Inc. on Aug 17, 2015 and is designated Class II. Reason for recall: Failed Stability Specifications: product may not meet specification limit for assay test. The recall status is terminated (terminated Jun 15, 2022). Affected quantity: 117,644 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 23, 2015
- Initiation Date
- Aug 17, 2015
- Termination Date
- Jun 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117,644 Bottles
Product description
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
Reason for recall
Failed Stability Specifications: product may not meet specification limit for assay test.
Distribution pattern
Nationwide and Puerto Rico
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1814-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026