Teva Pharmaceuticals has recalled one lot of Anagrelide Capsules, USP 0.5mg, due to dissolution failure during routine stability testing. The affected capsules belong to Lot #GD01090.
- There is no impact to members through Benecard Central
- Anagrelide capsules are indicated to treat thrombocythemia (secondary to myeloproliferative neoplasms) to reduce the elevated platelet count and risk of thrombosis as well as ameliorate associated symptoms, including thrombo-hemorrhagic events.
- If anagrelide capsules fail to properly dissolve, this may decrease the drug’s effectiveness. This could have lift-threatening consequences for seriously ill As of the recall date, Teva had received no quality complaints or reports of adverse events of this nature for the affected lot.
- Teva advises patients who have questions or concerns to first consult with their healthcare provider. For medical-related questions or to report an adverse event, Teva Medical Information can be reached at 1-888-838-2872 (option 3, then option 4) or druginfo@tevapharm.com. For product quality complaint-related questions, Teva Quality Assurance Services can be reached at 1-888-838-2872 (option 4).
- The S. FDA has published the full recall notice on its website.