Royal Pharmaceutical Society Advises On Counterfeit Casodex, UK

Main Category: Pharmacy / Pharmacist
Also Included In: Prostate / Prostate Cancer;  Urology / Nephrology
Article Date: 08 Jun 2007 - 1:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a recall on a counterfeit batch of Casodex Tablets 50 mg (Bicalutamide) with the lot number 65520. The Royal Pharmaceutical Society of Great Britain (RPSGB) advises pharmacists to check their stock for the counterfeit and to consult guidance available on the Society's website (www.rpsgb.org/pdfs/counterfeitmedsguid.pdf).

Pharmacists who identify counterfeit Casodex (used for the treatment of prostate cancer) should contact the manufacturers of the legitimate medicine, AstraZeneca, on tel: 0152 837 837 or for out of hours on tel: 01582 836 836. AstraZeneca are coordinating the recovery of the counterfeit on behalf of the MHRA. Pharmacists are advised not to return a suspected counterfeit to the original supplier.

The counterfeit Casodex was supplied in French livery via parallel importers. Evidence indicates that it has been distributed within the legitimate UK supply chain and may have reached patients. If a pharmacist is in receipt of these counterfeits they are advised to attempt to recover the tablets from patients.

Pharmacists are asked to note the following:

- Astra Zeneca routinely supplies the UK market with stock that is not parallel imported and is in UK branded livery. This stock is not affected and will bear the product licence number PL 17901/0005.

- None of the legitimate AstraZeneca stock bears the lot number in question.

- Parallel distribution companies sometimes add a prefix or suffix to the batch numbers to differentiate between them. These batch number variants are included in the scope of the recall.

- Parallel distribution companies may use a completely different lot number on the carton. If the lot number on the carton is not in the format of the quoted lot number above, with or without a suffix or prefix, pharmacists are advised to contact the parallel importer listed on the carton for clarification.

The MHRA is currently investigating a possible link between the counterfeit Casodex and the recent discovery of counterfeit Zyprexa, which also infiltrated the UK supply chain via parallel import from France. Initial MHRA laboratory tests indicate that the counterfeit contains approximately 75% of the active ingredient, Bicalutamide, which has rendered this drug alert necessary.

Ann Lewis, Secretary and Registrar at the RPSGB, said:

"The Society has been working with the MHRA through our team of inspectors and we ask pharmacists to cooperate with the MHRA's investigation and to inspect their stock for counterfeit medicines. We ask that pharmacists always be vigilant in the inspection of medicines that they receive to prevent the likelihood of counterfeits reaching patients, and to help us to work toward identifying any sources of counterfeit medicines."

Any pharmacist who has concerns about the authenticity of any other medicines that they hold in stock are advised to contact either their local Society inspector or the MHRA for guidance and advice.

The MHRA drug alert and question and answer document can be found on the MHRA website (www.mhra.gov.uk).

The AstraZeneca customer services team can be contacted on tel: 0152 837 837 or for out of hours on tel: 01582 836 836 to arrange the recovery of suspected counterfeit stock.