drugs Class III Updated 2014-12-10

Sandoz, Inc recalls candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx

Recalled Product

candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92

Hazard / Issue

Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 3007330, Exp 11/2014
View official government recall

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