Teva Pharma Recalls One Lot Of Anagrelide Capsules

(RTTNews) - Teva Pharmaceuticals USA, Inc. has recalled one lot of platelet-reducing drug Anagrelide in the form of capsules due to dissolution test failure detected during routine stability testing, the U.S. Food and Drug Administration or FDA said in a statement.

This is an expanded recall which was initiated on May 11, 2022. The recall has now been extended to the consumer/user level from the initial retail level.

The company noted that the administration of this product with lower dissolution, which takes longer to dissolve once ingested, may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect.

This failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. The less availability of anagrelide in the body, for seriously ill patients with elevated platelet counts, 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.

However, Teva said it has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot until now.

The recall involves one lot of Anagrelide Capsules USP 0.5 mg packaged in bottles with 100 gray and white capsules. The company noted that the recall only applies to 4224 bottles labeled with "Lot GD1090" and "Exp. Date of May 2022". No other lots of this product are impacted by the recall.

These bottles were distributed across the U.S. from July 30, 2020 through September 2, 2020 to its wholesale, distributor and retail customers under the label for Teva Pharmaceuticals USA, Inc.

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.

The Hawthorne, New York-based company has notified its customers and requested anyone with an existing inventory of the recalled lot to return the impacted product for a reimbursement.

However, Teva has warned consumers, patients or caregivers to consult with their pharmacist, healthcare provider or physician for advice about an alternative treatment prior to discontinuation of the medication.