Drugs watchdog points alert towards antacid Digene gel, Abbott initiates voluntary recall

Express News Service

NEW DELHI: The Drug Controller General of India (DCGI) has issued an advisory alert towards the favored Abbott’s antacid syrup, Digene gel, which is used towards acidity and fuel.

The firm introduced that it had withdrawn all its batches that had been being manufactured at its Goa facility following a criticism from a buyer that the liquid within the bottle had turned white, tasted bitter, and had a pungent odor once they purchased it in early August.

Digene gel is a sugar-free syrup that successfully acts towards acidity and fuel, reduces abdomen ache, and protects the abdomen from making extra acid for long-lasting reduction. The syrup, which is pink in color, has a sweetish style. It is out there in mint, orange, and blended fruit flavours.

The public discover issued on August 31 by Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, stated: “The impugned product may be unsafe, and its use may result in an adverse reaction.”

It additional issued advisory to docs, healthcare professionals, shoppers, wholesalers and distributors, and to regulatory authorities.

DCGI has requested docs and healthcare professionals to “carefully prescribe and educate their patients to discontinue the use and for reporting any ADRs (adverse drug reaction) arising due to consumption of the said product.”

“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product.”

It requested the shoppers to “discontinue” Digene Gel, manufactured on the Goa facility.

ALSO READ | Late marriages and way of life result in excessive infertility charges in south, says survey

The regulator has additionally instructed all state/UTs Drug Controllers and all zonal and sub-zonal officers of CDSCO to maintain a strict vigil on the motion, sale, distribution, and inventory of the stated drug merchandise available in the market, draw samples if the product is mendacity available in the market and provoke vital motion as per the provisions of the Drugs and Cosmetics Act and Rules.

According to Dr Shuchin Bajaj, Consultant Internal Medicine, Ujala Cygnus Group of Hospitals, the recalling of Digene Gel and the advisory issued on this regard by DCGI is in the most effective curiosity of the general public.

“It is to be noted that unsupervised and long-term usage of antacids can lead to kidney issues and other complications. Therefore, people should always consult a registered healthcare practitioner before consuming any medicine,” he instructed this paper.

One ought to take correct steerage on the dosage of such antacids and never devour any type of medication out of behavior, he added. “Besides, one should always watch out for the physical properties of the treatment they are consuming and immediately discontinue any medication that differs in appearance, smell, or taste as this could indicate subpar quality,” he additional stated.

Abbott India Limited initially withdrew one batch of its product out there in mint flavour and 4 batches in orange flavour after receiving the criticism. Later, inside every week, the corporate recalled all batches of Digene gel in all variants manufactured at its Goa facility.

“Abbott in India has voluntarily recalled Digene Gel antacid medication manufactured at our Goa web site resulting from remoted buyer complaints on style and odour. There have been no stories of affected person well being issues,” it stated.

It additionally stated that “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 DGCI stated that it was reported that the criticism was obtained on August 9 concerning the medication. following which on August 11, the corporate knowledgeable the DCGI workplace of a voluntary recall of the product below query.

Further, the corporate on August 18 had intimated to the DCGI workplace relating to the voluntary product recall of all batches of Digene Gel of all flavours (Mint, Orange, combine fruits flavour) that are throughout the self-life and manufactured on the Goa facility.

NEW DELHI: The Drug Controller General of India (DCGI) has issued an advisory alert towards the favored Abbott’s antacid syrup, Digene gel, which is used towards acidity and fuel.

The firm introduced that it had withdrawn all its batches that had been being manufactured at its Goa facility following a criticism from a buyer that the liquid within the bottle had turned white, tasted bitter, and had a pungent odor once they purchased it in early August.

Digene gel is a sugar-free syrup that successfully acts towards acidity and fuel, reduces abdomen ache, and protects the abdomen from making extra acid for long-lasting reduction. The syrup, which is pink in color, has a sweetish style. It is out there in mint, orange, and blended fruit flavours.googletag.cmd.push(perform() googletag.show(‘div-gpt-ad-8052921-2’); );

The public discover issued on August 31 by Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, stated: “The impugned product may be unsafe, and its use may result in an adverse reaction.”

It additional issued advisory to docs, healthcare professionals, shoppers, wholesalers and distributors, and to regulatory authorities.

DCGI has requested docs and healthcare professionals to “carefully prescribe and educate their patients to discontinue the use and for reporting any ADRs (adverse drug reaction) arising due to consumption of the said product.”

“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product.”

It requested the shoppers to “discontinue” Digene Gel, manufactured on the Goa facility.

ALSO READ | Late marriages and way of life result in excessive infertility charges in south, says survey

The regulator has additionally instructed all state/UTs Drug Controllers and all zonal and sub-zonal officers of CDSCO to maintain a strict vigil on the motion, sale, distribution, and inventory of the stated drug merchandise available in the market, draw samples if the product is mendacity available in the market and provoke vital motion as per the provisions of the Drugs and Cosmetics Act and Rules.

According to Dr Shuchin Bajaj, Consultant Internal Medicine, Ujala Cygnus Group of Hospitals, the recalling of Digene Gel and the advisory issued on this regard by DCGI is in the most effective curiosity of the general public.

“It is to be noted that unsupervised and long-term usage of antacids can lead to kidney issues and other complications. Therefore, people should always consult a registered healthcare practitioner before consuming any medicine,” he instructed this paper.

One ought to take correct steerage on the dosage of such antacids and never devour any type of medication out of behavior, he added. “Besides, one should always watch out for the physical properties of the treatment they are consuming and immediately discontinue any medication that differs in appearance, smell, or taste as this could indicate subpar quality,” he additional stated.

Abbott India Limited initially withdrew one batch of its product out there in mint flavour and 4 batches in orange flavour after receiving the criticism. Later, inside every week, the corporate recalled all batches of Digene gel in all variants manufactured at its Goa facility.

“Abbott in India has voluntarily recalled Digene Gel antacid medication manufactured at our Goa web site resulting from remoted buyer complaints on style and odour. There have been no stories of affected person well being issues,” it stated.

It additionally stated that “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 DGCI stated that it was reported that the criticism was obtained on August 9 concerning the medication. following which on August 11, the corporate knowledgeable the DCGI workplace of a voluntary recall of the product below query.

Further, the corporate on August 18 had intimated to the DCGI workplace relating to the voluntary product recall of all batches of Digene Gel of all flavours (Mint, Orange, combine fruits flavour) that are throughout the self-life and manufactured on the Goa facility.