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The National Agency for Food and Drug Administration and Control (NAFDAC) has received safety information from European Rapid Alert System for dangerous non- food products that a cosmetic product, Brown henna manufactured by India’s Royal Topline Exim Inc. has been banned.
The product contains Toluene-2,5-Diamine, 5-Amino-o-cresol, p-aminophenol and p-phenylenediamine (PPD) (measured values: 0.2%, 0.8%, 4.1% and 2.7%, respectively) with an insufficient coupling agent. Toluene-2,5-Diamine, 5-Amino-o-cresol, and uncoupled p-aminopohenol and PPD are extreme skin sensitizers and can trigger allergic contact dermatitis. Furthermore, Toluene-2,5-Diamine may cause cancer, is mutagenic and might affect fertility.
PRODUCT DETAIL
| PRODUCT NAME | MANUFACTURER | BATCH NO | BARCODE |
| Brown henna | India Royal Topline Exim Inc. (India) | 165 | 8901371090022 |
PRODUCT IMAGE
RECOMMENDATION
NAFDAC implores importers, distributors, and retailers of Cosmetic products to immediately stop importation, distribution, sale and use of Brown henna manufactured by India’s Royal Topline Exim Inc.
Members of the public in possession of the recalled lots of the product are implored to discontinue sale or use and handover stock to the nearest NAFDAC office.
NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng
REFERENCE
Safety Gate for dangerous non-food products (europa.eu)
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
