The Mumbai-based drug manufacturing company, Abbott India is recalling several batches of its popular antacid ‘Digene syrup’, as per reports. The recall was initiated following a customer complaint of a bitter taste and pungent odour.
As per the information received, Abbott India has taken this as a voluntary step and is recalling batches, particularly of the mint and orange-flavored syrup. The company added that it will also recall all batches of Digene Gel manufactured at the Goa unit.
Apart from this, the drug maker has also announced that it is voluntarily stopping the production of all variants of Digene Gel manufactured at their Goa facility.
The Drug Controller General of India (DCGI), the regulating body in India, issued a letter in this regard on 31st August. Citing a customer complaint, the DCGI letter stated, “On 9th August 2023, one bottle of Digene Gel Mint flavour used by the customer is of regular taste (sweet) and light pink colour whereas another bottle of same batch observed it was of white colour with a bitter taste and pungent odour as per the complaint.”
The drug regulator added that in response to the customer complaint, the drug maker informed them about their decision to recall the said products. The company announced, “for a voluntary recall of the impugned product Digene Mint flavour and Digene Gel orange and voluntarily stopped production of all variants of Digene Gel manufactured at their Goa facility.”
The letter added that the company has also informed the drug regulator about the “voluntary product recall of all batches of Digene Gel of all flavors – Mint, Orange, and Mix fruits flavors which are within the shelf life and manufactured at Goa facility.”
Confirming the development, Abbott India stated that it is going ahead with voluntary recall, however, it added that it was an “isolated customer complaint on taste and odour”.
“Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site due to isolated customer complaints on taste and odour,” an Abbott spokesperson was quoted saying in the News18 report.
However, the spokesperson stated that there were no reports of health concerns to the customer and maintained that their other forms of medication have not been impacted by this.
The spokesperson said, “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.”
DCGI writes to all healthcare professionals, issues alert
In a letter addressed to all drug regulators in states, Union Territories, and the Union Ministry of Health and Family Welfare, the DCGI stated that doctors and healthcare professionals should carefully prescribe and educate their patients to discontinue the use of the said product (recalled batches of Digene syrups, including all that were manufactured at company’s Goa facility).
It also asked healthcare professionals to report any side effects arising due to consumption of the Digene syrup.
“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product,” DCGI Rajeev Singh Raghuvanshi said.
Further, the DCGI official advised consumers and patients to discontinue the usage of Digene Gel which was manufactured at Abbott’s Goa facility.
The letter asked wholesalers and distributors to remove the impacted product with all batch numbers manufactured at the Goa facility within active shelf life from the distribution.
Earlier, in April, Abbott India had initiated a recall of a batch of medication used to treat hypothyroidism due to a labeling error.
Very important update regarding Digene gel
Digene gel is commonly used for treating acidity.
Abbott (makers of digene gel) have recalled digene gels of all flavours (mint, orange, mix fruit), manufactured at Goa facility, after a compaint was received regarding change in its… pic.twitter.com/eLhshOlTIv
— Dr Sudhir Kumar MD DM (@hyderabaddoctor) September 6, 2023
Following the directions of apex health regulators, doctors, and healthcare professionals have alerted patients regarding the same and have asked them to discontinue the usage of Digene antacid syrup, particularly manufactured at the Goa facility.