DCGI Issues Advisory As U.S.-Based Abbott Recalls Batches Of Digene Gel
"The impugned product may be unsafe and its use may result in adverse reaction," the DCGI letter dated August 31 said.
The DCGI has cautioned against the consumption of Abbott's antacid Digene gel citing safety concerns, even as the U.S.-based drugmaker recalled several batches of the medicine manufactured at its Goa facility.
According to a letter by the Drugs Controller General of India, it was reported on August 9 that a bottle of Digene Gel (mint flavour), batch no 51030307, used by customers was of regular taste (sweet) and light pink in colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour as per a complaint.
"Accordingly, M/s Abbott India Limited, Verna Industrial Estate, Salcette, Goa- vide letter dated August 11, 2023, informed DCGI office for voluntary recall of impugned product Digene Mint flavour batch no 510303D7 and Digene Gel orange having batch no 500351D7, 500352D7, 500353D7, 500354D7 and voluntary stopped production of all variants of Digene Gel manufactured at their Goa facility," the DCGI letter stated.
Further, Abbott India Limited, through a letter dated August 18, intimated to DCGI regarding 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," the DCGI letter dated August 31 said.
Meanwhile, the drug regulatory body has advised doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the medicine's use and for reporting of any ADRs (adverse drug reactions) arising due to consumption of the said product. Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product, it said.
To the consumers and patients, the DCGI has asked them to discontinue the use of Digene Gel which are manufactured at the Goa facility. As for wholesalers and distributors, the drugs body said the impacted product with all batch numbers manufactured at the Goa facility with active shelf life to be removed from the distribution.
Further the DCGI has instructed all regulatory authorities (states/UTs' drugs controllers, zonal and sub-zonal offices of CDSCO) to keep strict vigil on the movement, sale, distribution, and stock of the said drug products in the market, draw samples if the product still lying in market and initiate necessary action as per provisions of the Drugs and Cosmetics Act and Rules.
