The DCGI urged individuals to refrain from consuming Digene Gel. It also encouraged people to report any adverse effects.
Published Sep 06, 2023 | 5:15 PM ⚊ Updated Sep 06, 2023 | 5:17 PM
In a directive to consumers and patients, DCGI recommended discontinuing the use of Digene Gel manufactured in Goa. (Creative Common)
Pharmaceutical company Abbott India 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.
The DCGI urged individuals to refrain from consuming Digene Gel due to potential safety concerns. It also encouraged people to report any adverse effects they might encounter.
On 9 August, 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 11 August of its decision to voluntarily recall the affected product — specifically Digene (mint flavour) batch no 510303D7 — 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.
Very important update regarding Digene gel
Digene gel is commonly used for treating acidity.
Abbott (makers of digene gel) have recalled digene gels of all flavours (mint, orange, mix fruit), manufactured at Goa facility, after a compaint was received regarding change in its… pic.twitter.com/eLhshOlTIv
— Dr Sudhir Kumar MD DM (@hyderabaddoctor) September 6, 2023
Drugs Controller General Dr Rajeev Singh Raghuvanshi stated in a notification on 18 August that Abbott India also informed its office about the voluntary product recall of all batches of Digene Gel in various flavours that were still within their shelf life and manufactured at the Goa facility.
Raghuvanshi emphasised that the impugned product may pose safety risks, potentially leading to adverse reactions.
The DCGI also issued an advisory to healthcare professionals and doctors, urging them to exercise caution when prescribing and advising patients on the use of this product.
Healthcare professionals were encouraged to promptly report any suspicious cases of adverse events associated with this product.
In a directive to consumers and patients, the DCGI recommended discontinuing the use of Digene Gel manufactured in Goa.
Furthermore, wholesalers and distributors were instructed to remove all impacted product batches manufactured at the Goa facility within their active shelf life from distribution.
The DCGI also called upon Regulatory Authorities in all states and Union Territories to instruct their officers to closely monitor the movement, sale, distribution, and stock of these drug products in the market.
They were also advised to collect samples if the said product was found in the market and take necessary actions in accordance with the provisions of the Drugs and Cosmetics Act and Rules.
