November 08, 2019
Mylan Pharmaceuticals Inc. is recalling 4272 bottles of prasugrel tablets, 5 mg, because samples failed to meet dissolution specifications during testing, according to the November 6, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 30-count bottles (NDC 0378-5185-93) from lot 3089793 (Exp. 9/20). The affected bottles were distributed throughout the United States.
Mylan Pharmaceuticals voluntarily initiated the prasugrel recall October 18, 2019. On October 28, 2019, the FDA designated the recall Class II, communicating use of affected tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Prasugrel is a prescription blood thinner used to prevent blood clots.