Abbott India recalls batches of Antacid Digene gel

In its letter, the DCGI warned that Digene may be unsafe and its use may result in adverse reaction

US-based drugmaker Abbott has voluntarily recalled multiple batches of its popular Digene gel in India after the Drug Controller General of India (DCGI) issued an alert against the popular formulation, which is used to treat acidity and its associated symptoms, reported Livemint.

Digene came under the scanner after some patients complained of a "bitter taste" and "pungent odour".

In a letter dated August 31, the DCGI asked patients to avoid using Digene gel products originating from the company's manufacturing facility in Goa.

Furthermore, the drug control panel has directed wholesalers to withdraw all batches of the product that were manufactured at the Goa facility and are still within their active shelf life.

 

The DCGI's advisory further extends to healthcare professionals as well, with a request to "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."

"...on August 9 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 the same batch observed it was of white colour with bitter taste and pungent odour as per complaint," the letter read.

According to the letter, the pharmaceutical company voluntarily recalled batches of all flavours of Digene produced at the Goa facility.

The regulatory authority has also instructed relevant officers to watch the movement, sale, distribution, and stocking of Digene gel.

Earlier in April, Abbott had initiated a recall of a batch of medication used to treat hypothyroidism due to a labelling error.

"Abbott is recalling one batch [No. AEJ0713; Mfg. Date: March 2023] of Thyronorm, a medicine used in the treatment of hypothyroidism, in India, due to a labelling error that mislabeled the dose strength [mcg or microgram]," the pharmaceutical company had said.

Thyronorm is prescribed to patients with hypothyroidism, in which the thyroid gland does not produce sufficient quantities of the required hormones. Deficiency of thyroid hormones can disrupt heart rate, body temperature and metabolism.