Safety Report: Teva Anagrelide Capsules - recalled due to Dissolution Test Failure, USA

United States

Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.

The recalled product is:
Anagrelide Capsules, USP 0.5 mg
NDC: 0172-5241-60
Lot # GD01090
Exp. Date 05/2022

Administration of this product with lower dissolution – taking longer to dissolve once ingested -- may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life-threatening. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot.

Anagrelide capsules are indicated for the treatment of patients with 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. Information about the affected lot is listed in the table below. It is packed in bottles with 100 Capsules. Teva distributed 4224 bottles nationwide from 07-30-2020 through 09-02-2020 to its wholesale, distributor and retail customers under the label for Teva Pharmaceuticals USA, Inc.

Company name: Teva Pharmaceuticals USA
Brand name: Teva
Product recalled: Anagrelide Capsules
Reason of the recall: Dissolution Test Failure
FDA Recall date: May 23, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-anagrelide-capsules-usp-05-mg-due-dissolution-test