November 27, 2019
Dark-colored particles found during stability testing have prompted Teva Pharmaceuticals USA Inc. to voluntarily recall two lots of 100-mL bottles of valganciclovir hydrochloride for oral solution, 50 mg/mL, according to the November 27, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall includes more than 3500 bottles (NDC 0591-2579-20) from lots CBFCN and CBHFG (Exp. 5/20). The affected bottles were sent to wholesalers and distributors throughout the United States.
Teva Pharmaceuticals initiated the recall November 4, 2019. On November 21, 2019, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Valganciclovir hydrochloride is a prescription antiviral medication used to prevent or treat cytomegalovirus infection in adults after an organ transplant or with acquired immunodeficiency syndrome (AIDS).