Apotex Inc. recalls Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex
Recalled September 23, 2015 · FDA recall D-1814-2015 · Apotex
Hazard
Failed Stability Specifications: product may not meet specification limit for assay test. · FDA Class II
Units
117,644 Bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Stability Specifications: product may not meet specification limit for assay test.
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
Manufacturer(s)
Apotex Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →