The National Agency for Food and Drug Administration and Control NAFDAC, has alerted the public to the recall of certain batches of Zetol Antiseptic Products in Pakistan over safety and regulatory concerns.
In a statement, the agency said the recall followed a notification from the Drug Regulatory Authority of Pakistan, which revealed that the product is being marketed and sold in Pakistan without prior evaluation, registration, or approval.
According to NAFDAC, Zetol contains the antiseptic ingredient Chloroxylenol and is promoted for infection prevention despite lacking regulatory authorization. The agency also raised concerns over the product’s packaging, which closely resembles that of Dettol, a registered antiseptic, warning that this similarity could mislead consumers and encourage unsafe use.
NAFDAC warned that the use of the unregistered product, identified as “Zetol (Chloroxylenol) Germ Protection Liquid,” poses potential health risks since its quality, safety, and effectiveness have not been verified.
The affected product includes Zetol Antiseptic in 100ml and 1-litre pack sizes, with batch number BOOO1, manufactured by UNCUS Brothers, located along Multan Road in Lahore, Pakistan.
The agency emphasized that unregistered products distributed through unauthorized channels are unsafe and cannot be guaranteed to meet required standards.
NAFDAC said all its zonal directors and state coordinators have been directed to intensify surveillance and remove any unregistered or counterfeit versions of the product found within their jurisdictions.
Importers, distributors, retailers, healthcare professionals, and consumers have been urged to exercise caution across the supply chain and avoid the importation, sale, or use of unregistered medical products.
The agency advised that all medicines and related products should only be obtained from licensed suppliers, with careful checks on authenticity and physical condition before use.
Healthcare professionals and the public are encouraged to report suspected cases of substandard or falsified medical products to the nearest NAFDAC office or through its official channels.
NAFDAC also urged the reporting of adverse drug reactions via its pharmacovigilance systems, including its online reporting platforms and mobile applications.
The agency noted that the alert will also be uploaded to the World Health Organization Global Surveillance and Monitoring System to support global monitoring efforts.