Abbott Recalls Batches Of Digene Antacid Gel, DCGI Issues Alert

The Drugs Control General of India (DCGI) has issued an advisory alert regarding Abbott's antacid product, Digene gel.

In response to the alert, the regulator has advised patients to discontinue the use of Digene Gel produced at Abbott's Goa facility. Wholesalers have been instructed to remove affected products with all batch numbers that were manufactured at this facility and are within their active shelf life from distribution.

Healthcare professionals have also been urged by the DCGI to "carefully prescribe and educate their patients to discontinue the use and report any adverse drug reactions (ADRs) arising from the consumption of the said product."

Additionally, the regulator has directed state/union territory/zonal and sub-zonal officers to closely monitor the movement, sale, distribution, and stock of these drug products in the market. They are also advised to draw samples if the product is found in the market and take necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules.

In response to the advisory, an Abbott spokesperson stated, "Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints on taste and odor. 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."

The voluntary recall came after a customer complaint on August 9, 2023, which reported discrepancies in the taste, color, and odor of Digene Gel Mint flavor from the same batch. Abbott India Limited informed the DCGI office of the voluntary recall of the specific Digene Mint flavor batch flagged by the customer, as well as three other Digene Gel orange flavor batches. The company also voluntarily ceased production of all variants of the product manufactured at the Goa facility on August 11. Furthermore, on August 18, Abbott informed the DCGI office of the voluntary product recall of all batches of Digene Gel, including Mint, Orange, and mixed fruits flavors, that were within their shelf life and produced at the Goa facility.