The Central Drugs Standard Control Organisation (CDSCO) has alerted healthcare professionals, consumers, patients, wholesalers, distributors, and regulatory authorities about the voluntary recall of Abbott India’s popular antacid syrup Digene Gel, manufactured at its Goa facility.
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The public notice issued by the apex drug controller on its website said: “The impugned product may be unsafe and its use may result in adverse reaction.”
The Drugs Controller General of India (DCGI), who heads the CDSCO, also advised the doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the use and to report any adverse drug reactions arising due to consumption of Digene Gel.
“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product,” the DCGI stated in the letter.
The drug controller’s notice said the company initially withdrew one batch of its product available in mint flavour and four batches in orange flavour after receiving a complaint about a product that was white, had bitter taste and pungent smell early August. Within a week the company recalled all batches of its Digene syrup sold in mint, orange, and mixed-fruit flavours manufactured at its Goa facility.
CDSCO said it was reported on August 9 that one bottle of Digene Gel Mint Flavour used by customers was of regular taste (sweet) and light pink colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour as per the complaint.
Abbott India Limited informed the drug controller of the voluntary product recall and voluntarily stopped production of all variants of Digene Gel manufactured at their Goa facility.
CDSCO also urged distributors and users to discontinue the use of Digene Gel manufactured at the Goa facility while stating that there is no need to panic.
The drug is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas. It can be prescribed for gastritis (inflammation of the stomach lining) and acid reflux (a condition where stomach acid flows back to the food pipe). It uses basic compounds like magnesium hydroxide to neutralise the stomach acid.
Abbott spokesperson on Wednesday noted that the company had voluntarily recalled the antacid medicine manufactured at 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 other production site is in Baddi,” the spokesperson added.