Class I Drug Recall: Anagrelide Capsules, USP 1 mg

12/30/2020

On December 16, 2020, the FDA requested that Batch BFD1G001 of prescription Anagrelide Capsules, USP 1 mg. manufactured in India for Torrent Pharma, Inc., be removed from the market due to failed dissolution specifications. Anagrelide is used to decrease the number of platelets (a type of blood cell that is needed to control bleeding) in the blood of patients who have a bone marrow disorder, such as essential thrombocythemia, polycythemia vera, or chronic myelogenous leukemia (CML).

Member Impact

Approximately 6 Priority Health Medicare members are impacted by this recall. Letters have been sent to these members with next steps they can take if they aren't first contacted by their pharmacy.

What do providers need to do?

There's no action for providers. Dispensing pharmacies are contacting any patients who have received a recalled product and may be able to replace with product not from that batch, or from a different manufacturer.

Questions? contact our provider helpline at 800.942.4765.