Abbott India's Antacid Digene Gel Recalled After Regulator Alert

The Drug Controller General of India said that the Digene Gel manufactured at the Goa plant could pose safety risks and lead to harmful reactions.

Batches of Digene Gel manufactured at Abbott India's Goa factory have been recalled.

Source : Amazon India website

Antacid Digene Gel, produced by Abbott India at its Goa facility, has been recalled after Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi, issued an advisory to stop the use of the product. The advisory was issued after the regulator received a complaint on August 9, alleging differences in the taste, colour, and smell of Digene Gel (mint flavour) in bottles from the same batch, reported news agency IANS. One bottle had a regular sweet-tasting gel with a light pink colour, while the gel from another bottle of the same batch was white and had a pungent odour.

The DCGI said that the Digene Gel manufactured at the Goa plant could pose safety risks and lead to harmful reactions.

The apex drug controller, Central Drugs Standard Control Organisation, stated on its website: "The impugned product may be unsafe and its use may result in adverse reaction." It urges people to stop using Digene gel produced at the Goa facility. Accoding to a report by Indian Express, doctors say there's no need to panic, but anyone who takes this over-the-counter medication for an extended period of time should consult with their doctor. Digene in tablet form, on the other hand, is safe to take.

Acidity and its symptoms, such as heartburn, stomach discomfort, abdominal pain, and gas, are known to be relieved by the pink liquid — or its pill form. It is used to treat gastritis (inflammation of the stomach lining) and acid reflux (when stomach acid flows back into the food pipe). To neutralise stomach acid, it employs basic compounds such as magnesium hydroxide.

According to the public notice, the company initially recalled one batch of its mint-flavored product and four batches of its orange-flavored product after receiving a complaint about a product that was white, bitter, and odorous. Within a week, the company recalled all batches of Digene gel sold in mint, orange, and mixed fruit flavours made at its Goa plant.

CDSCO has directed all zonal and state drug controllers to monitor the movement, sale, distribution, and stock of the aforementioned Digene gel. "Draw samples if the said product is on the market and initiate necessary action in accordance with the provisions of the Drugs and Cosmetics Acts and Rules..." said the notice. It requested that all wholesalers and distributors remove all impacted products that were still on the shelf from distribution. Doctors and healthcare professionals have also been asked to educate their patients about the need to stop using the impacted medication. It also advises them to avoid any negative reactions to its consumption as soon as possible.