Batches of Digene Gel made in India recalled, drug regulator issues warning

The Drugs Controller General of India has issued an advisory against Digene Gel as US-based manufacturer Abbott recalled several batches of the antacid made in their Goa factory.

According to a letter by the Drugs Controller General of India (DCGI), 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 51030307 and Digene Gel orange having batch no 50035107, 50035207, 50035307, 50035407 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 the Goa facility. "The impugned product may be unsafe and its use may result in adverse reaction," the DCGI letter dated August 31 said.

(with PTI inputs)