The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi, has issued a cautionary notice regarding the usage of the antacid known as Digene Gel, which is produced by Abbott India at their Goa facility.
This advisory comes in response to a complaint filed on August 9th, which alleged discrepancies between two bottles of Digene Gel mint flavor from the same batch. One bottle was described as having a regular sweet taste and a light pink color, while the other bottle was white in color and had a bitter taste and pungent odor.
The DCGI has expressed concerns that the product manufactured at the Goa facility may pose safety risks and could lead to adverse reactions.
The advisory instructs healthcare professionals to exercise caution when prescribing Digene Gel and to educate their patients about discontinuing its use. Additionally, they are urged to report any adverse drug reactions (ADRs) associated with the product promptly. The DCGI recommends the removal of all batches of the product within their active shelf life from distribution.
Furthermore, the DCGI has called upon the Drug Controllers of various States and Union Territories to closely monitor the movement, sale, distribution, and stock of Digene Gel in the market. They are also encouraged to collect samples if the product is found in the market and take necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules.
Abbott India, in response to the situation, voluntarily recalled the affected product and ceased the production of all variations of Digene Gel manufactured at their Goa facility, in accordance with regulatory guidelines.
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