Abbott India has temporarily halted the production of Digene Gel at its manufacturing facility in Goa following a customer complaint regarding the antacid’s unusual discoloration, off taste, and odor. The company swiftly initiated corrective actions upon receiving the complaint.
In response to the issue, Abbott India initiated a recall of all batches of Digene Gel, including flavors like mint, orange, and mixed fruit, that were produced at the Goa facility and remained within their shelf life. Production of all variants at the Goa facility was also temporarily ceased. The company has kept the Goa Food and Drug Administration (FDA) informed about the situation and is actively cooperating with the regulatory authority.
The matter initially came to light on August 9 when a customer reported an abnormal appearance and taste in a bottle of Digene Gel Mint flavor, which differed from the usual sweet taste and light pink color. Abbott India promptly reported the incident to the Drug Controller General of India office and initiated a voluntary recall of one batch of Digene Mint flavor and three other batches of orange flavor on August 11.
Subsequently, on August 18, Abbott India expanded the voluntary recall to encompass all batches of Digene Gel across all flavors.
The Central Drugs Standard Control Organisation (CDSCO), India’s drug regulatory body, issued an advisory on August 31 concerning Digene Gel. The CDSCO advised healthcare professionals and doctors to exercise caution when prescribing the product and to inform patients about discontinuing its use if necessary. They also encouraged prompt reporting of any adverse reactions resulting from its consumption. Additionally, consumers were advised to stop using Digene Gel manufactured at Abbott’s Goa facility.
The CDSCO directed wholesale distributors to withdraw products with active shelf life from distribution and mandated strict monitoring of the drug’s movement, sale, distribution, and stock in the market by regulatory officers. If the product is found in the market, necessary actions will be taken in accordance with the Drugs and Cosmetics Act and Rules.
The Goa FDA conducted an inspection of the Abbott India plant from August 24 to September 2 to assess compliance and address the issue.
