FDA Takes Stringent Action Against Digene, Citing Health & Safety Concerns
The Food and Drug Administration (FDA) has stopped the sale of Digene, an antacid made by Abbott Company, due to a lot of complaints and safety worries.
Speaking to Pune Pulse, Shyam Pratapvar, Assistant Commissioner, FDA Pune, said “CAPD, the Chemist Association of Pune District, has directed that Digene antacid be recalled from the market forthwith. Chemists are also required to recall their stocks of the affected medicine. Wholesalers and distributors are also required to remove the affected products from their distribution channels. Precautions have been taken to control the movement, sale and distribution of the affected product.”
As per further information from Pratapvar, Abbott has voluntarily recalled its antacid, Digene antacid, manufactured at its Goa plant. The decision comes after an alert was issued by the Drug Controller General of India (DCGI) on August 31 to discontinue Digene antacid due to possible health risks. The alert was issued following isolated customer complaints about the gel’s unusual colour and bitter taste, as well as its pungent odour.
FDA Pune region has launched inspections on chemists selling Digene antacid in the district. The chemists have been asked to stop selling the product made at Abbott’s Goa plant.
The problem appears to be connected to five separate batches, all of which have been recalled from the company’s Goa plant.
The company will take samples of the medicine from its distribution chain for laboratory testing. If any violations or quality issues are found, the company will take appropriate action.
Patients are advised to wait for further instructions from central and state FDA authorities. Even though the medicine is still in circulation, The Chemist Association will follow the instructions of the drug authorities in order to ensure public safety.
