Apotex Inc. recalls Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx On
Recalled November 12, 2014 · FDA recall D-0243-2015 · Apotex
Hazard
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. · FDA Class III
Units
11,062 bottles
Sold at
Nationwide.
Description
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Product
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Manufacturer(s)
Apotex Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →