RECALLS

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RECALL: Durogesic transdermal patches

Further batches of Durogesic (fentanyl) transdermal patches 50µg/h, 75µg/h and 100µg/h are being recalled by Janssen-Cilag because stability samples have failed to meet specifications for ethanol content at 12 months, which may reduce transdermal delivery of the drug. This recall is in addition to the recall of 56 batches of Durogesic patches earlier this year.

The company says there is no expected imminent patient safety risk. The recall is to lessen any potential under-dosing related to a reduced fentanyl delivery rate. Any remaining stock of these batches should be quarantined and returned to suppliers for credit or replacement.

Further details from Janssen-Cilag customer services on 0800 7315550. For medical queries contact 0800 7318450. Affected batches could have been available as parallel imports from Munro Wholesale Medical Supplies, Denfleet International, P. I. E. Pharma, OPD Laboratories, G-Pharma and S. and M. Medical. Suppliers of any parallel imported products should be contacted directly.

A detailed recall notice is available from the Medicines and Healthcare products Regulatory Agency (PDF 65K)