Legal Central Ministry of Health & Family Welfare Essential Commodities Act, 1955

Voluntary Recall of Digene Gel manufactured by M/s Abbott India Limited, L-18 /19, verna Industrial Estate, Salcette, Goa-403722

31-Aug-2023 | NA

Central Drugs Standard Control Organization has issued a notification regarding the voluntary recall of Digene Gel, which is manufactured by M/s Abbott India Limited, located at L-18/19, Verna Industrial Estate, Salcette, Goa-403722. The key points from the Notification are:

1. Voluntary Recall: There is a voluntary product recall of all batches of Digene Gel, including all flavors (Mint, Orange, Mix fruits flavor), that are within their shelf life and were manufactured at the Goa facility. The reason for this recall is that the product may be unsafe, and its use may lead to adverse reactions.

2. Advisory to Healthcare Professionals:

Doctors and healthcare professionals are advised to carefully prescribe and educate their patients to discontinue the use of Digene Gel. They should also encourage patients to report any adverse drug reactions (ADRs) resulting from the consumption of this product. Healthcare professionals should promptly report any suspicious cases of adverse events associated with this product.

3. Advisory to Consumers and Patients:

Consumers and patients are advised to discontinue the use of Digene Gel that was manufactured at the Goa facility.

4. Advisory to Wholesalers and Distributors:

Wholesalers and distributors are instructed to remove all impacted products with batch numbers manufactured at the Goa facility and within their active shelf life from distribution.

5. Advisory to Regulatory Authorities:

Regulatory authorities, including all States/UTs Drugs Controllers and all Zonal and Sub-Zonal Offices of CDSCO, are advised to keep strict vigilance on the movement, sale, distribution, and stock of the mentioned drug products in the market. They should draw samples if the said product is found in the market and initiate necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder.

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Voluntary Recall of Digene Gel manufactured by M/s Abbott India Limited, L-18 /19, verna Industrial Estate, Salcette, Goa-403722

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Voluntary Recall of Digene Gel manufactured by M/s Abbott India Limited, L-18 /19, verna Industrial Estate, Salcette, Goa-403722

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