DCGI issues advisory as US-based Abbott recalls batches of Digene gel

The DCGI has cautioned in opposition to the consumption of Abbott’s antacid Digene gel citing security considerations, even because the US-based drugmaker recalled a number of batches of the medication manufactured at its Goa facility.

In accordance with a letter by the Medication Controller Common of India (DCGI), it was reported on August 9 {that a} bottle of Digene Gel (mint flavour), batch no 51030307, utilized by prospects was of standard style (candy) and light-weight pink in color whereas one other bottle of the identical batch was of white color with bitter style and pungent odour as per a criticism.

“Accordingly, M/s Abbott India Restricted, Verna Industrial Property, Salcette, Goa- vide letter dated August 11, 2023, knowledgeable DCGI workplace 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 manufacturing of all variants of Digene Gel manufactured at their Goa facility,” the DCGI letter acknowledged.

Additional, Abbott India Restricted, by way of a letter dated August 18, intimated to DCGI relating to voluntary product recall of all batches of Digene Gel of all flavours (mint, orange, combine fruits flavour) that are throughout the shelf life and manufactured at Goa facility.
“The impugned product could also be unsafe and its use might end in hostile response,” the DCGI letter dated August 31 stated.Maenwhile, the drug regulatory physique has suggested medical doctors and healthcare professionals to rigorously prescribe and educate their sufferers to discontinue the medication’s use and for reporting of any ADRs (hostile drug reactions) arising attributable to consumption of the stated product. Healthcare professionals ought to promptly report any suspicious circumstances of hostile occasions linked to this product, it stated.To the shoppers and sufferers, the DCGI has requested them to discontinue using Digene Gel that are manufactured on the Goa facility. As for wholesalers and distributors, the medication physique stated the impacted product with all batch numbers manufactured on the Goa facility with lively shelf life to be faraway from the distribution.

Additional the DCGI has instructed all regulatory authorities (states/UTs’ medication controllers, zonal and sub-zonal workplaces of CDSCO) to maintain strict vigil on the motion, sale, distribution, and inventory of the stated drug merchandise available in the market, draw samples if the product nonetheless mendacity in market and provoke vital motion as per provisions of the Medication and Cosmetics Act and Guidelines.