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Sandoz, Inc recalls candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by

Recalled December 10, 2014 · FDA recall D-0288-2015 · Sandoz

Hazard
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. · FDA Class III
Units
6,336 bottles
Sold at
Nationwide

Description

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.

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
Manufacturer(s)
Sandoz, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Sandoz, Inc recalls candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by | RecallWatchUSA