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Pfizer unit recalls generic drugs

Greenstone LLC, Pfizer's generic drugs unit, has announced a voluntary recall affecting two products due to the possibility that a third-party manufacturer may have placed incorrect labels on the pill bottles

Greenstone LLC, Pfizer's generic drugs unit, has announced a voluntary recall affecting two products due to the possibility that a third-party manufacturer may have placed incorrect labels on the pill bottles.

The recall covers one lot number that includes the generic antidepressant citalopram and finasteride, a generic version of Merck's benign prostatic hyperplasia drug Proscar, distributed in the US. The bottles labelled as citalopram may actually contain finasteride and vice versa, according to Pfizer.

The mix-up raises the possibility of serious adverse events, as finasteride is in the US Food and Drug Administration's (FDA) pregnancy category X, which means that it is known to cause harm to the developing foetus. Women who are or may become pregnant should not take or even handle finasteride because the drug can cause abnormalities to the genitalia of a developing male foetus.

The possible mix-up also has the potential to cause problems because citalopram is contraindicated in patients taking monoamine oxidase inhibitors or pimozide. In addition, patients who discontinue citalopram abruptly by inadvertently taking the mislabelled product could experience discontinuation symptoms or worsening of their depression.

The recall, which extends to the patient level rather than only to wholesalers as is sometimes the case, includes citalopram 10mg tablets and finasteride 5mg tablets with the lot number FI0510058-A on the label.

Consumers should alert their doctors immediately if they think they may have taken the wrong drug, Pfizer said. In addition, any adverse events possibly related to the recalled products should be reported to Pfizer or to the FDA.

Citalopram, which was originally sold by Lundbeck under the brandname Celexa, has been off-patent since 2003 and is available as a generic from a number of manufacturers. The drug is approved in the US to treat major depression and is used off-label for conditions including anxiety. Finasteride is marketed by Merck under the tradename Proscar for BPH; generic versions have been available since 2006.

Peapack, New Jersey-based Greenstone became a wholly owned subsidiary of Pfizer when the pharma giant bought Pharmacia in April 2003.

28th March 2011

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