FDA-Drug2014-11-12Class III
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
Apotex Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Sold states
Nationwide.
Affected count
18,493
Manufactured in
150 Signet Drive, N/A, Toronto, N/A, Canada
Products
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0242-2015Don't want to check this manually?
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