Class 2 Medicines Recall: Dysport 500 Units Powder for Solution for Injection
Drug alert number: EL(22)A/36
Date issued: 22 August 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:
Dysport 500 Units Powder for Solution for Injection PL 34926/000
Batch Number
Expiry Date
Pack Size
First Distributed
U14534
11/2023
1 x 500U vial
unknown
Active Pharmaceutical Ingredient: clostridium botulinum type A toxin-haemagglutinin complex
Brief description of the problem
The Medicines and Healthcare products Regulatory Agency (MHRA) has been investigating a report of a falsification of the above product in the UK.
The UK Marketing Authorisation Holder has confirmed that the batch above is falsified and has been supplied by unauthorised distributors to the UK.
See below for further details on identifying the falsified packs. This is also referenced in a Medical Product Alert issued by the World Health Organization (RPQ/REG/ISF/Alert N°4/2022):
The falsified carton in the UK includes an incorrect serialisation number (DYN7PCXH84UNBF) and an incorrect GTIN number (03582186006207)
This recall is to remove falsified products from the supply chain. The MHRA has not received any reports indicating patient harm related to this issue but will monitor the situation closely.
Advice for healthcare professionals
Stop supplying the above falsified batch immediately. Quarantine all remaining stock and return it to your supplier for onward investigation by Ipsen Limited.
If patients felt unwell after the administration of the affected batch above, please report this to the Marketing Authorisation Holder and complete a Yellow Card report via the MHRA Yellow Card scheme.
Full drug alert can be viewed here.
Advice for patients
Patients are not required to take any action at this time. This product is administered by healthcare professionals only.
If you are concerned about this notification, please contact your healthcare professional. If you have an adverse reaction after administration of Dysport, please seek medical attention. Side effects should also be reported via the MHRA’s Yellow Card scheme.
Further Information
For medical information enquiries, please contact Ipsen Limited at medinfo.uk-ie@ipsen.com
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