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Beta-Blockers Recalled Over Label Mix-Up


May 16, 2019

Zydus Pharmaceuticals USA Inc. is recalling a single lot of carvedilol tablets, 6.25 mg, after a bottle containing the tablets was incorrectly labeled as acyclovir tablets, 400 mg, according to the May 15, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 500-count bottles of 6.25-mg carvedilol tablets (NDC 68352-093-05) manufactured by Cadila Healthcare Ltd. and distributed in the United States by Zydus Pharmaceuticals. The affected tablets are from lot Z804517 (Exp. 11/30/20).  

Zydus Pharmaceuticals voluntarily initiated the recall April 25, 2019. The FDA designated the recall Class II on May 7, 2019. The designation warns use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Carvedilol is a prescription beta-blocker used to treat high blood pressure and heart failure. Acyclovir is a prescription antiviral used to treat cold sores, shingles, chickenpox, and other herpes infections. 

Jolynn Tumolo

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