DCGI issues advisory about Digene Gel following Abbott’s voluntary recall

The advisory instructs healthcare professionals to promptly report any suspicious cases of adverse events linked to this product

The Drugs Controller General of India (DCGI) has issued an advisory urging patients and healthcare professionals against the use of Digene Gel post the voluntary recall initiated by Abbott. Recommending an immediate halt in its use, the advisory states, “Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product.”

The advisory strongly advises consumers and patients to discontinue the use of Digene gel manufactured at Abbott’s Goa facility. It also directs wholesalers and distributors to remove all batches of the product from the distribution network that were manufactured at the Goa facility and are still within their active shelf life.

State drug controllers have also been told to closely monitor the movement, sale, distribution, and stock of these specific drug products in the market. “If said product lying in the market initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder,” instructs the DCGI letter.

Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints on taste and odour. There have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs are not impacted and Digene Gel manufactured at our other production site is not affected and continues to be available in sufficient quantities to meet current demand,” informed a statement from Abbott.

AbbottDCGIDigene GelDrugs Controller General of Indiavoluntary recall
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