Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: ANAGRELIDE HCL, Capsule, 0.5 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46414_1, EXP: 5/16/2014.
ANAGRELIDE HCL, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172524160.
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 Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Reason Failed Dissolution Specifications
Reason Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
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