The directive applies to batches of drug produced by Abbott India Limited at its Goa facility

The Drugs Control General of India (DCGI) has issued a notice advising doctors and patients to halt the use of Digene Gel, a popular antacid produced by Abbott India Limited at its Goa facility. This move comes in response to a complaint filed by a customer who identified discrepancies within a batch of Digene Gel Mint flavor.

The complainant noticed that one bottle of the Mint flavor exhibited a regular sweet taste and a light pink color, while another bottle from the same batch had a white color with a bitter taste and a pungent odor. This complaint, filed on August 9, 2023, triggered a series of actions by the regulatory authorities.

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

Abbott, the manufacturer of Digene Gel, took action by voluntarily recalling the specific Digene Mint flavor batch flagged by the customer. In addition to this, three other Digene Gel Orange flavor batches were also recalled. Besides, production of all versions of Digene Gel at the Goa facility was suspended.

On August 18, the company expanded the recall to include all batches of Digene Gel in all flavors (Mint, Orange, mixed fruits) that are within their shelf life and were produced at the Goa facility.

The DCGI advised the doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the use and to report any adverse drug reactions (ADRs) arising due to consumption of the Digene Gel.https://t.co/XtXCGHuRKJ pic.twitter.com/khYCxez51P

— Anup Soans (@anupsoans) September 6, 2023

Abbott released a statement, saying, “Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints on taste and odour. There have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs, are not impacted, and Digene Gel manufactured at our other production site is not affected and continues to be available in sufficient quantities to meet current demand.”

The DCGI has urged healthcare professionals to guide their patients in discontinuing the use of Digene Gel and to report any adverse drug reactions (ADRs) resulting from its consumption. Regulatory authorities are closely monitoring the movement, sale, distribution, and stock of Digene Gel products in the market. They have been empowered to draw samples if the product is still available and take necessary actions in accordance with the provisions of the Drugs and Cosmetics Act and Rules.

Patients and healthcare providers have been advised to stay informed and exercise caution until the issue is fully resolved.

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