May 16, 2019
Zydus Pharmaceuticals USA Inc. is recalling a single lot of acyclovir tablets, 400 mg, after a bottle was discovered to contain carvedilol tablets, 6.25 mg. The recall is included in the May 15, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 100-count bottles of 400-mg acyclovir tablets (NDC 68382-791-01) manufactured by Cadila Healthcare Ltd. from lot Z804517 (Exp. 11/30/20). The bottles were distributed throughout the United States by Zydus Pharmaceuticals.
Zydus Pharmaceuticals voluntarily initiated the recall April 25, 2019. On May 7, 2019, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Acyclovir is a prescription antiviral used to treat cold sores, shingles, chickenpox, and other herpes infections. Carvedilol is a prescription beta-blocker used to treat high blood pressure and heart failure.