BackAbbott India recalls antacid Digene Gel, DCGI issues advisory
State drugs controllers have been advised to keep strict vigil on the movement, sale and distribution and stock of the said products in the market, draw samples if the product is lying in the market, and initiate necessary action
PremiumNew Delhi: Drugmaker Abbott India has voluntarily recalled several batches of antacid Digene Gel, following which the Drug Controller General of India (DCGI) issued an advisory against using the product. The regulator said that the impugned product, manufactured at the company’s Goa unit, may be unsafe, and could result in adverse effects when consumed.
DCGI had received a complaint on 9 August, alleging bitter taste and pungent odour of the antacid.
Simultaneously, the government has advised doctors to avoid prescribing the medicine to patients and educate them on possible adverse reactions on consumption of the product.
“Patients to discontinue Digene Gel which are manufactured at Goa facility," the communication said adding that all wholesalers and retailers have also been asked to remove the product from distribution and sale.
“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," said a spokesperson of Abbott in a reply to Mint’s query.
State drugs controllers have been advised to keep strict vigil on the movement, sale and distribution and stock of the said products in the market, draw samples if the product is lying in the market, and initiate necessary action as per the provisions of the Drugs and Cosmetic Act and Rules.
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