Public Alert No. 038/2022 – Alert on Falsified DYSPORT (Clostridium botulinum type A toxin-haemagglutinin complex) identified in the WHO Regions of Europe and Eastern Mediterranean
August 30, 2022,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the general public of five falsified batches of DYSPORT detected in five countries – Jordan (May 2022), Türkiye (May 2022), Kuwait (June 2022), United Kingdom (June 2022) and Poland (July 2022) by the World Health Organization (WHO).
According to WHO, the products identified in this Alert has been confirmed by the genuine manufacturer IPSEN as falsified on the basis that they deliberately/fraudulently misrepresent their identity and source. The variable data (batch numbers, manufacturing and expiry dates) are falsified, there are discrepancies in the packaging languages, printing errors on the cartons and vial types.
Genuine DYSPORT is indicated to treat symptoms of cervical dystonia, glabellar lines (wrinkles) and spasticity and is administered intramuscularly.
The safety, sterility and quality of the falsified DYSPORT are not known. The administration of the products may pose a particular high risk to patients.
The details of the suspected DYSPORT 500Units are as follows;
Product Name: DYSPORT 500U
Stated Manufacturer: IPSEN
|Country identified in||Jordan, Poland,
NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the falsified batch of product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the falsified product are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via email@example.com or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng