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DCGI issues alert on Abbott India's antacid Digene gel manufactured in Goa facility

Our Bureau, New Delhi
Thursday, September 7, 2023, 08:00 Hrs  [IST]

The Drugs Controller General of India (DCGI) has issued alert on Abbott India's antacid product Digene gel manufactured in its Goa facility, after the company informed that some batches of the product were complained to be of different colour and taste than what is normal.

Based on the information, the drug regulator asked the state, Union Territory drugs controllers and all zonal and sub-zonal offices of Central Drugs Standard Control Organisation (CDSCO) to instruct its officers to keep strict vigil on the movement, sale, distribution, stock of the drug product in the market, draw samples if the product is lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules.

The regulator advised the wholesalers and distributors that the impacted product with all batch numbers manufactured at Goa facility within active shelf life to be removed from the distribution.

Abbott India Ltd has informed the drug regulator that it has stopped production of all variants of its antacid consumer care product Digene gel manufactured in its Goa facility and issued a voluntary recall of the products manufactured in the site.

The enforcement division of the Central Drugs Standard Control Organisation (CDSCO) said that it was reported on August 9, 2023 that one bottle of Digene gel mint flavour of a particular batch used by customer is of regular taste of sweet and light pink colour whereas another bottle of same batch was observed as of white colour with bitter taste and pungent odour as per a complaint.

Accordingly, Abbott on August 11, 2023 informed the division about the voluntary recall of the particular batches of Digene mint and orange flavours. It also informed the regulator that it voluntarily stopped production of all variants of Digene gel manufactured at their Goa facility.

It also informed voluntary product recall of all batches of Digene gel of all flavours (mint, orange, mix fruits flavour) which are within the shelf life and manufactured at Goa facility.

"The impugned product may be unsafe and its use may result in adverse reaction," said the regulator.

The CDSCO advised the doctors and healthcare professionals that they should carefully prescribe and educate their patients to discontinue the use and for reporting any adverse drug reactions (ADRs) arising due to consumption of the said product. Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product, it added.

According to the company website, Digene gel is a sugar-free syrup for effective action against acidity, with a scientifically developed combination of active ingredients that provides a highest ANC (acid neutralising capacity) property. It comes in mint, orange and mixed fruit flavours and is available in 200 ml and 450 ml packs.

 
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