13.09.2022
To the attention of all interested persons (users, distributors etc.)
The National Agency of Medicines and Medical Devices in Romania warns all users of benzocaine-containing local anaesthetic TOPIGEL, manufactured by LABORATORIOS CLARBEN, SA, Spain, wrongly classified as medical devices (class I), to immediately stop using it and return the products to the distributors from whom they purchased them and to report each their own situation to the National Agency for Medicines and Medical Devices of Romania – Marketing Surveillance Service.
The National Agency for Medicines and Medical Devices of Romania warns all distributors of benzocaine-based local anaesthetic, TOPIGEL, manufactured by LABORATORIOS CLARBEN, SA, Spain to immediately stop making this product available on the Romanian market, to notify the National Agency of Medicines and Medical Devices of Romania regarding the stock held and the suppliers from whom they obtained these products.