Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: W003649, EXP: 6/25/2014.
CANDESARTAN CILEXETIL, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00186001631.
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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