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The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert warning Nigerians about the circulation of an unregistered condom brand known as Foula Condoms.
NAFDAC said officials from the Post-Marketing Surveillance Directorate discovered Foula condoms (packaged in threes) in Abakaliki, Ebonyi State, and Zango, Katsina State.
The agency said the product is not registered for use in Nigeria, stressing that the labelling of the product is not in the English language.
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It added that the discovery was made during a Risk-Based Post Marketing Surveillance study on registered condoms in Nigeria.
“The Foula brand of condoms is not registered by NAFDAC for use in Nigeria, and the product’s labeling is not in English, which raises additional safety concerns,” stated NAFDAC.
“Condoms are essential as an effective barrier method to prevent unintended pregnancies and protect against HIV and other sexually transmitted infections. However, they must be registered and meet quality standards to ensure safety and efficacy.”
It stated that the illegal distribution or sale of unregistered condoms poses a risk as the safety, quality, and efficacy of the products are not guaranteed.
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“The purchase and use of poor-quality condoms will adversely affect every aspect of condom promotion for the prevention of unintended pregnancy, and protection against HIV and other Sexually Transmitted Infections. If condoms leak or break, they cannot offer adequate protection.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the unregistered products within the zones and states. Importers, distributors, retailers, healthcare professionals, and consumers are hereby advised to exercise caution and vigilance within the supply chain to avoid importing, distributing, selling, and using illegally distributed products.
“All medical products/ medical devices must be obtained from authorised/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 or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: [email protected]
“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 [email protected],” NAFDAC stated.
Similarly, the agency warned Nigerians to avoid the recall of Nivea Black & White Invisible Roll-on deodorant, 50ml.
NAFDAC issued a warning against the product labelled as providing 48-hour protection in African climates, following an equal warning from the European Union Rapid Alert System for Dangerous Non-Food Products in Brussels.
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In a notice released on Thursday, NAFDAC stated that the product’s batch number is 93529610.
“The recalled Nivea product is reported to contain 2-(4-tert-Butylbenzyl)
propionaldehyde, a chemical prohibited in cosmetic products due to its potential to cause harm to the reproductive system, impair the health of an unborn child, and cause skin irritation and burns to users,” the agency explained.
NAFDAC added that the product is manufactured in Germany with Bar Code Number 42299882.
It advised importers, distributors, retailers, and consumers to exercise caution and vigilance within the supply chain to prevent the importation, distribution, sale, and use of the affected Nivea Roll-on with the specified batch.
“Members of the public in possession of the affected batch should cease sale or use and submit stock to the nearest NAFDAC office.
“Healthcare professionals and consumers are encouraged to report any adverse events experienced with the use of regulated products to the nearest NAFDAC office, via [email protected], E-reporting platforms available at www.nafdac.gov.ng, or through the Med-safety application available for download on Android and iOS,” it added.
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