FDA-Drug2015-09-23Class II
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
Apotex Inc.
Hazard
Failed Stability Specifications: product may not meet specification limit for assay test.
Sold states
Nationwide and Puerto Rico
Affected count
117,644 Bottles
Manufactured in
150 Signet Drive, Toronto, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1814-2015Don't want to check this manually?
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