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