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Recipharm Audit Results in Licence Restriction

Five non-critical highly potent products from the Ashton-u-Lyne, UK site suspended due to potential cross contamination risk

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By: Kristin Brooks

Managing Editor, Contract Pharma

Following a routine audit, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has restricted the manufacturing license for five non-critical highly potent products supplied from the Recipharm facility located in Ashton-u-Lyne, UK. This was due to deficiencies in certain manufacturing procedures which represented a potential cross contamination risk.

Recipharm’s facility in Ashton-u-Lyne, primarily manufactures non-potent solid dose products. Highly potent products are manufactured in a separate dedicated area.

Following the audit, production was immediately suspended to determine the risks. The company is working with the MHRA and customers regarding remediation plans. These plans have been endorsed by the MHRA and are being executed. Supply has recommenced and will continue in a phased manner for the non-restricted products. It is unlikely that this issue will cause significant supply interruptions and it is expected that the license restriction will be lifted by the end of the year.

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