A popular antacid, Digene, has come under scanner after complaints of its bitter taste and pungent odor came to light. Following this, the drug maker Abbott India has recalled several batches of the antacid.
In a letter dated 31st August, the Drug Controller General of India (DCGI) stated: “…on 9th August 2023, one bottle of Digene Gel Mint flavour used by the customer is of regular taste (sweet) and light pink colour whereas another bottle of same batch observed it was of white colour with bitter taste and pungent odour as per complaint.”
According to the letter, as seen by Financial Express.com, the pharmaceutical company has voluntarily recalled batches of mint and orange-flavoured Digene. Moreover, the company has also decided to stop the production of all variants of Digene gel manufactured at their Goa Facility.
In its letter, the drug regulator also warned that the impugned product may be unsafe and its use may result in adverse reaction.
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.
In a statement shared over E-mail, Abbott India told Financial Express.com: “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.”
DCGI has asked patients to discontinue the use of Digene Gel manufactured at the company’s Goa facility. Additionally, it has instructed wholesalers to remove impacted product with all batch numbers manufactured at the facility within active shelf life from distribution.
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”.
Meanwhile, it has asked the other regulatory authorities to instruct their officer to keep strict vigil on the movement, sale, distribution, stock of the 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.”
(DISCLAIMER: The story has been updated with Abbott India’s statement shared over email after publishing the story.)
