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
Recall Number: D-1814-2015
Firm: Apotex Inc.
Classification: Class II
Status: Terminated
Report Date: 20150923
Initiation Date: 20150817
Termination Date: 20220615
Reason for Recall
Failed Stability Specifications: product may not meet specification limit for assay test.
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