The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public about the recall of certain batches of Zetol Antiseptic Products in Islamabad, Pakistan, due to a quality defect.
The Drug Regulatory Authority of Pakistan (DRAP) has stated that this product is being marketed and sold in Pakistan without prior evaluation, registration, or approval from the Drug Regulatory Authority of Pakistan (DRAP).
Zetol contains an active antiseptic ingredient (Chloroxylenol) and is being promoted with claims of infection prevention, despite lacking regulatory authorization. Additionally, its packaging closely resembles that of a registered antiseptic brand, Dettol, which may mislead consumers and increase the risk of inappropriate use of this unregulated product.
Risk Statement
Use of the unregistered antiseptic product “Zetol (Chloroxylenol) Germ Protection Liquid” may pose a potential risk to public health, as it has not been evaluated or approved, and so its quality, safety, and efficacy cannot be guaranteed.
Product Details
The details of the product are as follows:
No. | Product Name | Pack size | Composition | Batch Details | Manufacturer Name |
1 | Zetol Antiseptic | 100ml, 1 Litre | Chloroxylenol | BOOO1 | UNCUS BROTHERS Address: 23 KM Multan Road, Lahore |
Product Photo
NAFDAC wants to stress that unregistered products sold through unauthorized distribution channels are unsafe, and their effectiveness and quality are not guaranteed.
All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove any unregistered or counterfeit products that may be present in their respective zones and states.
Importers, distributors, retailers, healthcare professionals, caregivers, and consumers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the SF product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines, medical devices, or any NAFDAC-regulated product to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………….Customer-focused, Agency-minded!!!
