Teva is voluntarily recalling a single lot of Anagrelide Capsules, USP 0.5mg, due to dissolution failure that was detected during a routine stability test.
Anagrelide is indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.
Ingesting a drug that takes longer to dissolve may result in decreased effectiveness or ineffectiveness. For patients with elevated platelet counts, less anagrelide in the body could increase the risk of clotting and the potential for heart attack or stroke.
The recalled product has an NDC number of 0172-5241-60, lot number of GD01090 and expiration date of May 2022. The capsules are packaged in 100-count bottles; a total of 4224 bottles were distributed nationwide from July 30, 2020 through September 2, 2020.
The Company states that they have not received any adverse event reports related to this recall.
Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Teva issues voluntary nationwide recall of one lot of anagrelide capsules, USP 0.5 mg due to dissolution test failure. News Release. US Food and Drug Administration. Accessed May 26, 2020. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-anagrelide-capsules-usp-05-mg-due-dissolution-test