Drug Safety Alerts

Anagrelide 0.5 mg Capsules Consumer-Level Recall

5/20/2022

On May 20, 2022, Teva Pharmaceuticals USA, Inc. issued a consumer-level recall of Anagrelide 0.5 mg capsules NDC #00172-5241-60. This recall was issued due to dissolution test failure detected during routine stability testing.

This recall affects lot GD01090 exp. 05/2022.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. 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. For seriously ill patients with elevated platelet counts, less available anagrelide 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. According to Teva, it 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.

Teva Pharmaceuticals USA, Inc. recommends that patients should continue taking Anagrelide 0.5 mg Capsules until they obtain replacement product or a prescription for an alternative product.

CVS Caremark Response: Because of this action, CVS Caremark is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking these products to contact their prescriber.

For more information about this recall, please call Teva Pharmaceuticals USA, Inc. toll-free at 1-888-838-2872, Monday-Friday between 9:00 AM and 5:00 PM (EST). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.