Pharmaceutical company Abbott India has initiated a recall of several batches of the popular antacid Digene Gel in response to an advisory issued by the Drugs Controller General of India (DCGI) cautioning against its use.
The DCGI raised concerns about the safety of Digene Gel and urged individuals to avoid consuming the product while also encouraging the reporting of any adverse effects.
On August 9, a consumer reported an issue with Digene Gel (mint flavor) batch number 510303D7. The complaint highlighted discrepancies between two bottles from the same batch. One bottle had a regular sweet taste and a light pink color, while the other exhibited a white color with a bitter taste and pungent odor.
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 flavor) batch number 510303D7, along with Digene Gel orange batches 500351D7, 50035207, 500353D7, and 50035407.
Additionally, Abbott India Limited ceased production of all variants of Digene Gel at its Goa facility.
The DCGI issued an advisory stating that the impugned product may pose safety risks and could lead to adverse reactions. Healthcare professionals and doctors were urged to exercise caution when prescribing or advising patients on the use of this product and to promptly report any suspicious cases of adverse events.
Consumers and patients were recommended to discontinue the use of Digene Gel manufactured in Goa. Wholesalers and distributors were instructed to remove all affected product batches manufactured at the Goa facility within their active shelf life from distribution.
Regulatory authorities in all states and Union Territories were called upon 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 product was found in the market and take necessary actions in accordance with the provisions of the Drugs and Cosmetics Act and Rules.