The Central Drugs Standard Control Organisation (CDSCO) has issued a public notice regarding the voluntary recall of Abbott India’s popular antacid syrup, Digene Gel, produced at its Goa facility. The apex drug controller stated that the product may pose safety concerns leading to adverse reactions.
The Drugs Controller General of India (DCGI), who leads the CDSCO, advised healthcare professionals to prudently prescribe and inform their patients to cease using the product. They also encouraged reporting any adverse reactions linked to Digene Gel.
The company initially withdrew specific batches of the product, including mint and orange flavors, after a complaint in early August about a product’s irregularities. Subsequently, all batches of Digene syrup in mint, orange, and mixed-fruit flavors from the Goa facility were recalled.
On August 9, it was reported that one bottle of Digene Gel Mint Flavour had a regular taste and light pink color, while another bottle from the same batch was white with a bitter taste and pungent odor.
Abbott India Limited informed the drug controller of the voluntary product recall and halted production of all variants of Digene Gel from their Goa facility.
CDSCO advised distributors and users to discontinue the use of Digene Gel from the Goa facility, assuring that there was no need to panic.
Digene Gel is known for relieving acidity and related symptoms like heartburn, stomach discomfort, abdominal pain, and gas. It can be prescribed for conditions like gastritis and acid reflux, utilizing basic compounds like magnesium hydroxide to neutralize stomach acid.
An Abbott spokesperson mentioned on Wednesday that the company had voluntarily recalled the antacid medicine from its Goa site due to isolated customer complaints about taste and odor. They emphasized that there have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs, are unaffected, and Digene Gel from their other production site in Baddi remains readily available to meet current demand.
