DCGI flags popular antacid Digene Gel, Abbott initiates recall

Issuing a cautionary advisory, the regulatory body has urged patients to discontinue the use of Digene Gel manufactured at Abbott's Goa facility. Furthermore, it has directed wholesalers to withdraw any affected product, including all batch numbers manufactured at the facility that are within their active shelf life, from distribution.

DCGI has called upon healthcare professionals to be diligent in their prescribing practices and to educate their patients on discontinuing the use of this product. They are also encouraged to promptly report any adverse drug reactions (ADRs) linked to the consumption of Digene Gel.

"The doctors and healthcare professionals should carefully prescribe and educate their patients to discontinue the use and for reporting of any ADRs (adverse drug reactions ) arising due to consumption of the said product. Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product," read the advisory issued by Rajeev Singh Raghuvanshi, DCGI.

In addition, the regulator has instructed state/UT/zonal and sub-zonal officers to closely monitor the movement, sale, distribution, and stock of Digene Gel in the market, and has further directed them to draw samples if the product is found in the market and take necessary action in accordance with the provisions of the Drugs and Cosmetics Act and Rules.

As per a letter issued by the Drug Controller General of India (DCGI) on August 31, it was revealed that on August 9, 2023, a customer reported that one bottle of Digene Gel Mint flavor from the same batch had a regular taste (sweet) and a light pink color, while another bottle exhibited a white color with a bitter taste and a pungent odor, as stated in the complaint.

Following this complaint, the company promptly informed the top health regulator and requested a "voluntary recall of the impugned product Digene Mint flavor" and "Digene Gel orange." Furthermore, they voluntarily ceased production of all variants of Digene Gel manufactured at their Goa facility.

The letter also disclosed that the company had informed the drug regulator about the "voluntary product recall of all batches of Digene Gel of all flavors - Mint, Orange, and Mix fruits flavors - manufactured at a Goa-based facility."

Accordingly, the Mumbai-based company has taken voluntary action to recall specific batches, particularly those of the mint and orange-flavored syrup variants. Additionally, the company has made the decision to halt production voluntarily for all versions of Digene Gel that are manufactured at their Goa facility. They will also recall all batches of Digene Gel produced at the Goa unit.

An Abbott spokesperson stated, "Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints regarding taste and odor. There have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs, remain unaffected, and Digene Gel manufactured at our other production site remains readily available to meet current demand."