Drug maker Abbott India is recalling several batches of popular antacid Digene syrup after a complaint of bitter taste and pungent odour, News18 has learnt.
The Mumbai-based company is voluntarily recalling batches, especially of the mint and orange-flavoured syrup. Also, the company has decided to voluntarily stop the production of all variants of Digene Gel manufactured at their Goa facility. It will also recall all batches of Digene Gel manufactured at the Goa unit.
According to the letter issued by the Drug Controller General of India (DCGI) on August 31, “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 bitter taste and pungent odour as per complaint (sic)”.
Following the complaint, the company informed the apex health regulator “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…,” said the letter accessed by News18.
Further, the letter said the company has informed the drug regulator about the “voluntary product recall of all batches of Digene Gel of all flavours – Mint, Orange, and Mix fruits flavours – manufactured at a Goa-based facility.”
Abbott India confirmed to News18 that it is going ahead with voluntary recall after 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 said in a response to an email.
“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.”
Doctors must carefully prescribe this antacid: DCGI
According to the letter written by DCGI — marking all drug regulators across states, Union Territories and the Union Ministry of Health and Family Welfare — doctors and healthcare professionals should carefully prescribe and educate their patients to discontinue the use and 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,” wrote DCGI Rajeev Singh Raghuvanshi in the letter.
He has advised consumers and patients to discontinue the use of Digene Gel manufactured at Goa facility.
To wholesalers and distributors, the letter said, “The impacted product with all batch numbers manufactured at the Goa facility within active shelf life is to be removed from the distribution.”
In April, Abbott initiated a recall of a batch of medication used to treat hypothyroidism due to a labelling error.
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