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[UK] Recall of counterfeit olanzapine (Zyprexa®) 10mg batches

posted Saturday, 26 May 2007

The Medicines and Healthcare products Regulatory Agency (MHRA) has been alerted to three counterfeit batches of Zyprexa (Olanzapine) 10 mg tablets. This drug is used in the treatment for patients with schizophrenia, bipolar disorder and similar conditions including as an adjuvant to antidepressants.

The MHRA has issued a drug alert to recall this product from the market, to minimise the risk to patients. To date, it is believed that two of the batches have reached patient level. A criminal investigation is underway. One person has been arrested and is on bail.

Initial laboratory tests on the seized counterfeits show that the samples contain approximately 60% of the labeled active ingredient. As counterfeit may also contain harmful ingredients additional testing is being undertaken to determine if the counterfeit tablets contain additional ingredients.

Patients should contact their pharmacist as soon as possible, if they are taking medication from the following; Zyprexa (Olanzapine) 10mg tablets with the batch numbers A229505, A200127, A216454 (or one of these numbers with a prefix or suffix). Take the medication with you so the pharmacist can return it to Eli Lilly (the manufacturer) for examination.

Please be aware of the following issues concerning lot numbers:-
  1. Parallel distribution companies may have added a prefix or suffix to the lot number, such as A200127/1 to differentiate different packing runs. These lot number variants are included in the scope of the recall.
  2. Parallel distribution companies may occasionally use a completely different lot number on the carton. If the lot number on the carton is not in the format 'AXXXXXX or AXXXXXX/X' recipients are advised to contact the parallel distributor listed on the carton for clarification.

At present there is no evidence of patients having any adverse reactions specifically related to the counterfeit batches. Patients should consult their GP if they have any treatment or health concerns.

Patients with concerns can contact Eli Lilly on 0800 032 0741.

MHRA recall alert...

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