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PRODUCT ALERT: Herceptin (trastuzumab) 150mg injection (ALL BATCHES) (22 November 2006)

The European Medicines Agency and Roche Registration Ltd have issued an alert for all batches of Herceptin injection 150mg vials containing powder for reconstitution following the discovery of a number of cracked vials, which may result in non-sterility of the contents. Recipients are requested to inspect any vials in their possession in accordance with the document “Instructions for visual inspection: Herceptin vials 150mg”, accessible via the safety information section of the Medicines and Healthcare products Regulatory Agency website.

Any defective vials should be quarantined and returned to Roche Products Ltd for replacement. Records of the inspection should be recorded on the document “Visual inspection reporting form: Herceptin 150 mg vials” (also available from the MHRA website) which should be faxed to the number quoted on the form.

Any departments unable to carry out the local inspections are asked to contact Roche Products Ltd on 01707 367835. Medical information enquiries on 0800 3281629.