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Voluntary Recall of One Lot of Anagrelide Capsules

On May 20, 2022, Teva Pharmaceuticals voluntarily recalled one lot of Anagrelide capsules, USP 0.5 mg, due to dissolution test failure detected during routine stability testing. Only this lot, NDC: 0172-5241-60; Lot Number: GD01090; Expiration Date: 05/2022, was impacted.

Administration of this product with lower dissolution may result in decreased effectiveness or ineffectiveness of the drug’s platelet-reducing effect. To date, Teva has not received any product quality complaints or adverse event reports for the recalled lot.

The impacted lot is packed in bottles of 100 capsules. Teva distributed 4,224 bottles nationwide from July 30, 2020 through September 2, 2020 to its wholesale, distributor and retail customers under the label for Teva Pharmaceuticals USA, Inc.

Consumers with questions or concerns should first consult with their health care professional(s).

For medical-related questions or to report an adverse event: Call Medical Information at 1-888-838-2872, option 3; then, option 4. You can call weekdays from 9 a.m. to 5 p.m., Eastern Time, or leave a voicemail, 24/7. Or, email druginfo@tevapharm.com.

For product quality complaint-related questions: Call Quality Assurance Services at 1-888-838-2872, option 4. You can call weekdays from 9 a.m. to 5 p.m., Eastern Time, or leave a voicemail, 24/7.

Read more about this recall.

Source:

Center for Drug Evaluation and Research. Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure. U.S. Food and Drug Administration. Retrieved on May 20, 2022 from fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-anagrelide-capsules-usp-05-mg-due-dissolution-test?utm_medium=email&utm_source=govdelivery.

Published on: June 6, 2022, 13:38 p.m. ET
Last updated on: June 6, 2022, 13:43 p.m. ET