DCGI issues advisory against Digene Gel; raises safety concerns after Abbott's voluntary recall

economictimes.indiatimes.com:

Drugs Controller General of India has issued an advisory for patients and healthcare professionals to discontinue the use of popular antacid Digene gel due to safety concerns after drugmaker Abbott initiated a voluntary recall of the impugned product.

According to the advisory by the drug regulator, doctors and healthcare professionals should carefully prescribe and inform their patients to «discontinue» its use. It has also asked them to report any adverse drug reaction (ADRs) arising due to its consumption.

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Consumers and patients have been advised to discontinue use of the product, manufactured at the drugmaker's Goa facility.

Moreover, wholesalers and distributors have been asked to remove the impacted product with all batch numbers manufactured at the Goa facility within active shelf life from the distribution network. In an advisory, state drug controllers have also been asked to keep a strict vigil on the movement, sale, distribution, stock of the said drug products in the market. They have been asked to draw samples if available in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules.
An Abbott India spokesperson told ET that it had «voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints on taste and odour.»