DCGI has asked healthcare professionals to “carefully prescribe and educate their patients to discontinue the use and for reporting of any ADRs (adverse drug reaction) arising due to consumption of the said product”.
The regulator has also instructed all state/UT/ zonal and sub-zonal officers to keep strict vigil on the movement, sale, distribution, stock of the said drug products in the market, draw samples if the product is lying in market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules.
The Drugs Control General of India (DCGI) has issued an advisory alert against Abbott’s antacid Digene gel.
The regulator has asked patients to discontinue the use of Digene Gel manufactured at the company's Goa facility and has instructed wholesalers to remove impacted product with all batch numbers manufactured at the facility within active shelf life to from distribution.
Management's response
Abbott spokesperson said, “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.” to Moneycontrol in response to an inquiry.
A customer had reported that one bottle of Digene Gel Mint flavor is of regular taste (sweet) and light pink colour, whereas another bottle of the same batch observed was of white colour with bitter taste and pungent odour, as per a complaint on August 9, 2023.
Abbott India Limited on August 11 had informed the DCGI office for a voluntary recall of the product under question - Digene Mint flavor batch flagged by the customer and three other Digene Gel orange flavor and voluntarily stopped production of all variants of the product manufactured at the Goa facility.
Further, the company on August 18 had intimated the DCGI office regarding voluntary product recall of all batches of Digene Gel of all flavors (Mint, Orange, mix fruits flavor) which are within the self-life and manufactured at Goa facility.
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