September 27, 2019
Torrent Pharma Inc. is recalling 2472 bottles of anagrelide capsules. According to the September 25, 2019, US Food and Drug Administration (FDA) Enforcement Report, “high out-of-specification results for impurities [were] detected during routine stability testing.”
The recall affects anagrelide capsules, 0.5 mg, in 100-count bottles (NDC 13668-453-01) from lot BFE2E003 (Exp. 8/31/20). The capsules were distributed throughout the United States and Puerto Rico.
Torrent Pharma initiated the voluntary recall September 6, 2019. The FDA designated it Class II on September 16, 2019. A Class II designation communicates use of the drug may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Anagrelide is a prescription blood thinner used to treat patients with thrombocythemia.