Drug Controller General of India (DCGI) has issued a cautionary advisory to doctors and healthcare professionals, urging them to inform patients about discontinuing the use of Digene gel in the event of an adverse drug reaction (ADR).
As per a TOI report, this move follows a recent complaint received by the DCGI regarding a batch of Digene gel produced by Abbott India in Goa. The complaint highlighted unusual characteristics, including an off-white color, a bitter taste, and a pungent odor in the mint-flavored variant of the popular anti-acidity formulation.
The advisory emphasizes the importance of healthcare professionals promptly reporting any suspicious cases of adverse events associated with Digene gel to the appropriate authorities. While Digene is generally considered a safe medication, this development has raised concerns about product quality.
Abbott India has reportedly recalled all products from the affected batch and halted production of all Digene gel variants at its Goa facility. A spokesperson for Abbott India told TOI that this voluntary recall was initiated due to isolated customer complaints regarding taste and odor. Importantly, the company confirmed that there have been no reports of health issues among patients who consumed the product.
However, the company spokesperson clarifies that the recall specifically applies to Digene gel manufactured at the Goa facility. Other forms of Digene, such as tablets and stick packs, remain unaffected. Digene gel from Abbott India's other production sites also