Class I — High risk. Reasonable probability of serious harm or death.
Failed Dissolution Specifications
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
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 Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Reason Labeling: Label Mixup: ANAGRELIDE HCL, Capsule, 0.5 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 2 mg, NDC…
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