US-based pharmaceutical company Abbott has taken the proactive step of recalling multiple batches of its popular Digene gel product in India. This recall comes in response to an alert issued by the Drug Controller General of India (DCGI) regarding this widely used formulation, primarily designed to alleviate acidity and its associated symptoms.
DCGI urged patients to exercise caution
The scrutiny surrounding Digene arose when some patients reported experiencing an unusual “bitter taste” and “pungent odor” associated with the product. In a letter dated August 31, the DCGI urged patients to exercise caution and advised against the use of Digene gel products originating from Abbott’s manufacturing facility in Goa.
Furthermore, the drug control panel has issued directives to wholesalers, instructing them to withdraw all batches of Digene gel that were manufactured at the Goa facility and are still within their active shelf life.
The DCGI’s advisory extends its reach to healthcare professionals as well, requesting them to be vigilant in prescribing and educating their patients about discontinuing the use of Digene and reporting any adverse drug reactions (ADRs) resulting from the consumption of the said product.
The letter from DCGI highlighted a specific incident that triggered concerns, stating, “…on 9th August 2023, one bottle of Digene Gel Mint flavor used by the customer is of regular taste (sweet) and light pink color, whereas another bottle of the same batch observed it was of white color with bitter taste and pungent odor as per complaint.”
In response to these regulatory concerns, the pharmaceutical company has voluntarily recalled batches of all flavors of Digene that were produced at the Goa manufacturing facility.
In addition to the recall, the regulatory authority has directed relevant officers to closely monitor the movement, sale, distribution, and stocking of Digene gel, ensuring the safety and well-being of consumers in India.
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