FDA-Drug2014-12-10Class III
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
Sandoz, Inc
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.
Sold states
Nationwide
Affected count
6,336 bottles
Manufactured in
506 Carnegie Ctr Ste 400, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2015Don't want to check this manually?
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