Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications; out of specification for Related Compound
Reason Failed Impurities/Degradation Specifications
Reason Out-of-specification organic impurity results obtained during routine stability testing.
Reason Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Reason Failed Impurities/Degradation Specifications; 9 month stability timepoint
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