RECALLS

Home > Recalls / Product alerts / Drug alerts

RECALL: Casodex (1 June)

The Medicines and Healthcare products Regulatory Agency and AstraZeneca are recalling parallel imported stock from lot 65520 (and lot variants, as described below) of bicalutamide tablets 50mg branded as Casodex, irrespective of livery, following the discovery of counterfeit tablets in the legitimate supply chain. Lot 65520 is a genuine AstraZeneca lot number for which the original unchanged lots were supplied to France in French livery.

Parallel import companies may have added a prefix or suffix to the lot number to differentiate separate packing runs. These lot number variants are included in the scope of the recall. In addition, parallel import companies may occasionally use a different lot number on the carton. If the lot number on the carton is not in the format of one of the quoted batch numbers (with or without a suffix or prefix), recipients are advised to contact the parallel importer listed on the carton for clarification.

This counterfeit product was supplied in French livery via parallel importers into the UK supply chain and both genuine product and counterfeit product may be present in the UK supply chain. French livery cartons with an overlabel applied by a parallel importer (or repackaged into a UK carton by the parallel import repacking process) may present a patient risk.

AstraZeneca routinely supplies Casodex to the UK market, which is not parallel imported and is in UK-branded livery. This stock, none of which has the above lot numbers or variants, is unaffected and bears the product licence number PL 17901/0005.

Recipients are asked to attempt to recover tablets from patients and quarantine any affected stock. To discuss the return of affected stock, telephone AstraZeneca customer services on 01582 837837 (for out of hours, telephone medical information on 01582 836836). The issue of reimbursement should be discussed with the original supplier and full records should be kept.