Digene Gel recall: Supplies will be reinforced from Baddi, says Abbott

PT Jyothi Datta Updated - September 07, 2023 at 09:54 PM.

Stocks made in Goa facility were recalled after customers’ complaints on “taste and odour”  

Distributors and wholesalers are asked to remove products if they are made in Goa and still had shelf life

Healthcare major Abbott said its Baddi plant (Himachal Pradesh) would supply additional stocks of the antacid Digene Gel, following a recent recall of the product made at its Goa plant. 

Abbott had voluntarily recalled Digene Gel made at its Goa facility “due to isolated customers’ complaints on taste and odour.”

A spokesperson for the company 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 demands.”

DCGI alert

Following the complaint made in early August, all batches of Digene gel (flavours mint, orange, of the mix fruits) made at the Goa facility, were recalled, according to an alert from the Drug Controller General of India. In fact, the plant stopped making all variants of Digene Gel , the DCGI alert said. 

Further, it advised doctors to educate patients and to watch out for and report possible adverse events, linked to the product. Distributors and wholesalers have been asked to remove the product, if it was made in Goa and still had a shelf life. The drug regulatory authority around the country was also alerted to watch for stocks of the said product. Company representatives said, they were working with local regulatory authorities to identify and remedy the problem.

In April, Abbot had initiated a voluntary recall on a mislabelled batch of Thyroid medicine Thyronorm, in Madhya Pradesh and Telangana.  In this case, the  company had said, “ The incorrect labelling was due to a human error by one of the third-party manufacturer plant operators, we are in the process of conducting an exhaustive investigation at the site, and will take corrective actions as required.”

Published on September 7, 2023 16:05

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