Teva Pharmaceuticals USA has issued a voluntary nationwide recall of one lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090). The consumer-level recall is being initiated due to failed dissolution test results from one lot. This was discovered during routine stability testing. No other lots are affected by this recall.
Risk Statement
When this drug is administered, it may take longer to dissolve, leading to reduced effectiveness or total ineffectiveness of its platelet-reducing effect.
Reduced or failed dissolution can result in extended drug release or a slower rate of drug release causing, leading to less anagrelide.
Less anagrelide in the body can result in ill patients with low platelet count, leading to the risk of clotting or bleeding events such as stroke or heart attack, which can be life-threatening.
Teva has not received any reports of adverse events related to this recall.
Indications
Anagrelide capsules are used in the treatment of a type of blood disorder known as thrombocythemia. Patients with thrombocythemia have high levels of platelets in the blood, which can increase their risk of bleeding or clotting events. It reduced the risks of thrombosis (blood clotting) and thromboembolism (blockage of veins or arteries).
The information about the affected lots is as follows.
NDC: 0172-5241-60
Lot: GD01090
Expiry: Exp. Date
The drug is packaged in bottles containing 100 capsules. Teva, under the label Teva Pharmaceuticals USA Inc., distributed 4224 bottles to wholesalers, distributors, and retailers nationwide from 07-30-2020 through 09-02-2020.
Teva has notified wholesalers, distributors, and retailers by letter and is arranging for the return of all recalled lots. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product should contact their healthcare providers immediately.
If you want to report any adverse events or have medical-related questions, contact medical information at Contact Medical Information at 888-838-2872 9:00 AM – 5:00 PM Eastern Time or send an email to [email protected].
For product quality complaints, contact quality assurance service at 888-838-2872 9:00 AM – 5:00 PM Eastern Time.
For any adverse reactions or quality issues, please contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch or call 1-800-FDA-1088.
This recall is conducted with the knowledge of the U.S. Food and Drug Administration (FDA)
