Five non-critical highly potent products supplied by contract development and manufacturing organisation (CDMO) Recipharm have had their manufacturing licence restricted.
Restrictions
The restrictions are due to deficiencies in certain procedures which represent a cross contamination risk and come from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
In particular, the restrictions are for five products supplied from Recipharm’s facility located in Ashton u-Lyne.
The restrictions come after a routine audit by the MHRA, following which production was immediately suspended to control the risks. In the meantime, Recipharm liaised with the MHRA and customers regarding remediation plans. The plans, which the MHRA has endorsed are now in motion. Supply has recommenced and will continue in a phased manner for the non-restricted products.
Recipharm does not believe that the issue will cause significant supply disruptions for patients. It’s expected that the restrictions will be lifted by the end of the year.