DCGI Issues Alert On Abbott's Digene Gel For Quality; Abbott Voluntarily Recalls Product In India
The Drug Controller General Of India (DCGI) Dr Rajeev Singh Raghuvanshi has red-flagged a Digene Gel product manufactured by the pharmaceutical company Abbott India. In a letter dated 31 August 2023, the DCGI issued an alert calling the impugned product 'unsafe' and the use of which may result in adverse reactions.
The DCGI advised the doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the use and to report any adverse drug reactions (ADRs) arising due to consumption of the Digene Gel.
"Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product," the DCGI stated in the letter.
It advised the wholesalers and distributors to remove all the batches of the product manufactured at the Goa facility within active shelf life from distribution. Further, the DCGI advised the consumers to discontinue the use of Digene Gel which is manufactured at Goa Facility.
Dr Raghuvanshi in the letter stated that on 9th August 2023, one bottle of Digene Gel Mint flavour batch no. 510902b' used by a customer was of regular taste (sweet) and light pink colour whereas another bottle of the same batch was observed to be of white colour with a bitter taste and pungent odour as per the complaint.
Accordingly, Abbott India informed the DCGI office of a voluntary recall of the impugned product Digene Mint flavour batch no. 510303D7 and Digene Gel Orange having batch no. 500351D7, 500352D7, 500353D7, and 500354D7 and voluntarily stopped production of all variants of Digene Gel manufactured at their Goa facility, the DCGI's letter read.
DCGI said following this Abbott India wrote to its office again on 18 August notifying about a complete recall of all the batches and flavours of the Digene Gel products which are within the shelf life and were manufactured at the pharmaceutical company's Goa facility.
Dr Raghuvanshi instructed all Regulatory Authorities of the country to keep strict vigil on the movement, state, distribution, and stock of the said drug products in the market, and draw samples. "If said product lying in the market initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder," the DCGI noted in the letter.
A spokesperson from Abbott India told BW Healthcare World that the company voluntarily recalled Digene Gel antacid medicine manufactured at the 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,” the spokesperson claimed.
(This story has been updated to add the response by the spokesperson from Abbott India)
