drugs Class III Updated 2014-11-12

Apotex Inc. recalls Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (ND

Recalled 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

Hazard / Issue

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15
View official government recall

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