Abbott recalls Antacid Digene gel in India, DCGI issues advisory alert on sale of medicine

Drug manufacturer Abbott India has recalled all batches of the antacid syrup, Digene gel, which were manufactured at its Goa facility. The Drugs Controller General of India (DCGI) has issued an advisory alert against Abbott’s antacid Digene gel. 

The medicine, which is pink in colour, was recalled after customers reported that the liquid in the bottle had turned white, tasted bitter and had a pungent smell when they bought it early August. 

The DCGI has asked patients and consumers to discontinue the use of the antacid gel manufactured at Abbott’s Goa plant due to safety concerns.  There have been no reports of patient health concerns. 

A public notice issued by the apex drug controller, on its website, said: “The impugned product may be unsafe and its use may result in adverse reaction.”  

It urged people to discontinue the use of Digene gel manufactured at the Goa facility.  

The regulator added the wholesalers should remove impacted product with all batch numbers manufactured at the facility within active shelf life to from distribution. 

DCGI has asked healthcare professionals to “carefully prescribe and educate their patients to discontinue the use and for reporting of any ADRs (adverse drug reaction) arising due to consumption of the said product”. 

Besides, it has also instructed all state/UT/ zonal and sub-zonal officers to keep strict vigil on the movement, sale, distribution, stock of the said drug products in the market, draw samples if the product is lying in market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules. 

Digene, available in both liquid and pill form, is used for is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas.

Mumbai-based Abbott India on August 11 had informed the DCGI office for a voluntary recall of the product under question - Digene Mint flavor batch flagged by the customer and three other Digene Gel orange flavor and voluntarily stopped production of all variants of the product manufactured at the Goa facility, Moneycontrol reported. 

Later on August 18, the company had informed the DCGI office regarding voluntary product recall of all batches of Digene Gel of all flavors (Mint, Orange, mix fruits flavor) which are within the self-life and manufactured at Goa facility. 

“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,” an Abbott spokesperson told Moneycontrol. 

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