Pharmaceutical company Abbott India has recalled multiple batches of the popular antacid Digene Gel.
Safety risks
The move came after an advisory issued by the Drugs Controller General of India (DCGI) cautioned against the use of the product.
It urged people to avoid consuming it due to potential safety concerns.
It also told people to report any adverse effects they might encounter.
Background
On 9 August, an incident was reported involving Digene Gel (mint flavour) batch no 510303D7.
The customer noted discrepancies between two bottles of the same batch.
One bottle exhibited a regular taste (sweet) and a light pink colour.
The other bottle from the same batch had a white colour with a bitter taste and a pungent odour.
Manufacturer issues recall, halts production
In response, Abbott India informed the DCGI on 11 August that it will 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 it halted production of all variants of Digene Gel at its Goa facility.
Drugs Controller General Dr Rajeev Singh Raghuvanshi stated in a notification on 18 August that Abbott India informed its office about the voluntary product recall of all batches that were still within their shelf life and manufactured at the facility.
He said that it may pose safety risks and potentially cause adverse reactions.
Doctors asked to be careful
The DCGI urged healthcare professionals and doctors to exercise caution when prescribing and advising patients on the use of this product.
They were also encouraged to promptly report any suspicious cases of adverse events associated with it.
Sellers asked to remove Goa facility product
Wholesalers and distributors were instructed to remove all impacted product batches manufactured at the Goa facility still within their active shelf life.
It 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 the concerned product.
They are to collect samples if they are found in the market and take necessary actions in accordance with the provisions of the Drugs and Cosmetics Act and Rules.
