Why is Abbott India recalling its antacid Digene gel?
What's the story
Abbott India has voluntarily recalled batches of its antacid Digene Gel manufactured at the company's Goa facility, following an advisory from the Drugs Controller General of India (DCGI).
The regulator warned that the product may be unsafe and could have adverse effects on consumption. It instructed wholesalers to remove impacted products from distribution.
It also advised doctors to avoid prescribing it to patients and educate them on potential adverse reactions.
Details
Customer brought case to light
The development came after the DGCI received a complaint from a customer on August 9 concerning a bottle of Digene Gel that had a pungent smell and white color, as opposed to the usual sweet flavor and light pink color.
Abbott India informed the DGCI on August 11 about voluntarily recalling the product. Although the complaint was related to the product's mint flavor, it stopped the production of all three flavors (mint, orange, and mixed fruit) at its Goa facility.
Details
Other forms of Digene available: Abbott
Meanwhile, Abbott's spokesperson said that there have been no reports of patient health concerns.
"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 company said.
This is significant because Digene is reportedly one of the most self-prescribed medicines in India, and customers rarely check the manufacturing location before consumption.
Vigil
State drugs controllers advised to keep strict vigil
State drug controllers have been advised to keep a close watch on the movement, sale, distribution, and stock of the aforementioned products in the market.
They have also been asked to collect samples if the product is still on the market and to take the required action in accordance with the Drugs and Cosmetic Act and Rules.
"Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product," wrote DCGI Rajeev Singh Raghuvanshi in a letter.
Recall
Abbott recalled batch of hypothyroidism medication in April
In April, the healthcare major initiated a voluntary recall on a batch of thyroid medicine, Thyronorm, in Madhya Pradesh and Telangana.
The product was recalled owing to a "labeling error that mislabeled the dose strength (mcg or microgram)," according to the firm. However, it stated that there were no quality issues with the product and that there had been no reports of patient harm.
Notably, Telangana's drug controller classified Thyronorm on the "Not of Standard Quality" list last year.