Class 4 FMD Drug Alert For Information: Kingsley Specials Ltd, Multiple Products

Class 4 FMD Drug Alert For Information: Kingsley Specials Ltd, Multiple Products

September 1, 2020

MDR number: 101-08/20

Drug alert number: EL (20)A/42

Date issued: 01 September 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 FMD Drug Alert For Information for:

 Kingsley Specials Ltd WDA(H) 49276, Multiple Products – see alert for more information

The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that does not hold a wholesale dealers authorisation and then sold it on to a number of other wholesalers.

The products do appear to be genuine with legitimate batch numbers and safety features. These products are thought to have left the legitimate supply chain and been reintroduced between March and August 2020. This means that the correct transport and storage conditions cannot be guaranteed and, while unlikely, could impact their effectiveness.

Only the products mentioned in appendix 2 (see here) are within the scope of this alert. Please follow the advice below if you have received any of the products listed in appendix 2 from:

  • WDA(H) 42332 Smartway Pharmaceuticals Limited
  • WDA(H) 20912 Drugsrus Limited
  • WDA(H) 48028 Optimal Pharma Limited

Please note, the above wholesalers did not procure the products listed directly from Kingsley Specials Ltd. These products were sold onwards by intermediate companies and the companies listed above are not implicated of any wrongdoing and are co-operating with the MHRA to resolve the matter.

Advice for healthcare professionals

Please check your stocks of all the listed products for the relevant batches supplied from the above companies. If any relevant packs are identified, please quarantine and notify the Defective Medicines Report Centre (DMRC)/MHRA.

The above wholesalers have implemented safety measures by decommissioning the impacted packs, changing the status to STOLEN/INACTIVE in the National Medicines Verification System (NMVS). When scanning the serialised 2D code, the status of packs will report as ‘STOLEN’ and/or ‘INACTIVE.’ These products have been shared with other wholesalers prior to procurement at pharmacy level, therefore please check with your supplier directly for more information of affected packs.

  • Healthcare professionals involved in dispensing the products listed in appendix 2 should ensure that appropriate scanning takes place at the point of dispensing/good received to highlight packs that may be impacted by this issue. Where they report as being ‘STOLEN’ and/or ‘INACTIVE’, they should not be dispensed. You should quarantine and notify the DMRC/MHRA.
  • Where there is no ability for scanning, healthcare professionals and wholesalers should consider using the unique serial number (SN) and/or product code (PC)/Global Trade Item Number (GTIN) information available on the outer packaging of the product. This information has been provided in Appendix 2 and is available on request from DMRC in other formations, if required.

Company contacts for further information

Smartway Pharmaceuticals Limited

Drugsrus Limited

Optimal Pharma Limited

View the full alert here 

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