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FDA Recalls Carvedilol Tablets

Zydus Pharmaceuticals USA Inc. is recalling 7668 bottles of carvedilol tablets, 3.125 mg, after a customer found a fragmented tablet of another drug product in a bottle. The recall was announced in the May 1, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall is for 500-count bottles from lot Z803518 (Exp. 8/20). Bottles from the affected lot were manufactured by Cadila Healthcare Ltd. and distributed throughout the United States by Zydus Pharmaceuticals.

Zydus Pharmaceuticals voluntarily issued the recall April 22, 2019. On April 25, 2019, the FDA designated the recall Class III, suggesting use of the affected product is unlikely to cause adverse health consequences.

Carvedilol is a prescription beta-blocker used to treat heart failure and hypertension.

Jolynn Tumolo

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