Class I · High risk Terminated
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC…
Reason Failed Dissolution Specifications
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
What was recalled
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
- Recalling firm
- Teva Pharmaceuticals USA Inc
- NDC code
- 0172-5241-60
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0992-2022
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.
Other Anagrelide recalls
See all
Class II · Moderate risk Terminated
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ…
Reason Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class II · Moderate risk Terminated
ANAGRELIDE HCL, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172524160.
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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