Following a warning from the Drug Controller General of India (DCGI), Abbott India has removed their Digene Gel product off the shelves. Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI), has issued a warning to stop using the antacid Digene Gel produced by the pharmaceutical company Abbott India at its Goa facility.
The DCGI issued the warning in response to a complaint made on August 9 that claimed one Digene Gel mint flavor bottle had a standard taste (sweet) and a light pink color, while another bottle from the same batch had a bitter taste and an offensive odor.
According to the DCGI, the contested product made at the Goa site may be dangerous, and using it might have negative effects.Physicians should carefully encourage patients to discontinue taking the medicine and report any adverse drug reactions (ADRs). According to Dr. Raghuvanshi’s new caution, doctors should report any suspected adverse effects related to this medicine promptly.
It also advised removing the product off the market while it was fresh.
The DCGI also requested that state and union territory drug controllers monitor the movement, sale, distribution, and stock of drug products, collect samples, and take legal action in accordance with the Drugs and Cosmetics Act and Rules.
Abbott India informed DCGI in a letter dated August 11 that it had voluntarily recalled the disputed product and had also ceased manufacturing of all Digene Gel versions produced at its Goa site in accordance with the regulation.
In the meanwhile, Abbott released the following statement: “Due to isolated customer complaints on taste and smell, Abbott in India has voluntarily recalled Digene Gel antacid medication made at our Goa location. No complaints of patient health issues have surfaced.
Digene Gel produced at our second production location is not affected and continues to be accessible in sufficient quantities to fulfill current demand, the statement said. “Other forms of Digene, such as tablets and stick packs, are not impacted.”
Conclusion:-
The Drug Controller General of India (DCGI) has issued a warning to Abbott India to stop using the antacid Digene Gel produced at its Goa facility. The warning was issued in response to a complaint on August 9 that claimed one bottle had a standard taste and a light pink color, while another had a bitter taste and an offensive odor. The DCGI deemed the contested product potentially dangerous and warned doctors and medical professionals to advise patients to stop using the product and report any adverse drug reactions. The product should be removed from the market while it still has an active shelf life. Abbott India informed DCGI that it had voluntarily recalled the disputed product and ceased manufacturing of all Digene Gel versions produced at its Goa site. The company stated that no complaints of patient health issues have surfaced and that other forms of Digene, such as tablets and stick packs, are not impacted.
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