New Delhi: The Drugs Controller General of India has issued an advisory alert against popular antacid, the Digene gel, by Abbott — asking patients to discontinue use of the drug manufactured at the company’s Goa facility.
The alert, issued on August 31, was made public Tuesday.
The DCGI has also instructed wholesalers to remove impacted products with specified batch numbers within active shelf life from Abbott’s Goa facility from distribution channels.
“The doctors and healthcare professionals should carefully prescribe and educate their patients to discontinue the use and report any adverse reaction event arising due to consumption of the said product,” the alert said.
The DCGI alert came after a customer reported on 9 August that one bottle of Digene’s mint flavour was pink in colour and tasted sweet — which was regular — while another bottle of the same batch was white and tasted bitter. It also had a pungent odour, the regulatory body said.
Following the complaint, the company informed the regulator on 11 August that it was voluntarily recalling Digene gel’s mint and orange flavours produced at its Goa facility.
A week later, on 18 August, the drugmaker informed the regulator that it was recalling Digene gel of all flavours (mixed fruits, mint and orange) produced at its Goa facility.
On being contacted for comments, an Abbot spokesperson insisted that it was a voluntary recall.
“Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints on taste and odour” the spokesperson said in a statement over email.
“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 demands,” the company said.