The Indian arm of US based pharmaceutical giant Abbott has recalled multiple batches of the popular antacid Digene Gel. This action comes in response to an advisory issued by the Drugs Controller General of India (DCGI), which cautioned against the use of the product.

Earlier, the DCGI urged people to refrain from using Digene Gel given potential safety concerns. It also encouraged people to report any adverse effects they might encounter.

On August 9, an incident was reported involving Digene Gel (mint flavour) batch no. 510303D7. In this case, a customer noted discrepancies between two bottles of the same batch.

One bottle exhibited a regular taste (sweet) and a light pink colour, while the other bottle from the same batch had a white colour with a bitter taste and a pungent odour, as per his complaint.

In response to these concerns, Abbott India informed the DCGI on August 11 of its decision to voluntarily recall the affected product—specifically Digene (mint flavour) batch no. 10303D7—as  well as Digene Gel orange with batch numbers 500351D7, 50035207, 500353D7, and 50035407.

Additionally, Abbott India Limited ceased production of all variants of Digene Gel at its Goa facility.

Drugs Controller General Dr Rajeev Singh Raghuvanshi announced that Abbott India has issued a voluntary product recall of all batches of Digene Gel manufactured at the Goa facility.

Pointing out that the recall is due to potential safety risks, including adverse reactions, DCGI advised healthcare professionals and doctors to exercise caution when prescribing and advising patients to use the product.

The DCGI further recommended discontinuing the use of Digene Gel manufactured in Goa, instructing wholesalers and distributors to remove affected batches from distribution.

It also called on regulatory authorities to closely monitor the movement, sale, distribution, and stock of the drug in the market.

If the product is found on the market, the authorities should collect samples and take necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules, the DCGI statement noted.