Pfizer, Genentech and APP initiate recalls

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Mislabeling, vial contamination, disturbing odors: they're familiar reasons for recent drug recalls. But they're also behind three new recalls launched over the past several days.

Pfizer is pulling two drugs distributed by its Greenstone unit, saying that labels might have been switched inadvertently. Bottles of the antidepressant Citalopram, the generic version of Celexa, may have been labeled as Finasteride, the prostate drug. Likewise, some Finasteride bottles may carry Citalopram labels.

Obviously, the two drugs aren't interchangable, so Pfizer says patients should return any suspect bottles to their pharmacist. The company says no injuries or illnesses have been linked to the labeling snafu. If this mess-up sounds familiar, it's because Mylan recently pulled two of its drugs for a similar label-switching problem.

Meanwhile, APP Pharmaceuticals has pulled five lots of its Irinotecan Hydrochloride Injection, a colorectal cancer treatment, because some vials were found to contain foreign particles. Once examined, the particles proved to be "a fungal microbial contaminant," the FDA said in a statement.

Finally, in a Dear Healthcare Professional Letter, FDA and Genentech say 13 lots of the oral cancer treatment Xeloda have been recalled on reports of a mothball-like odor or taste in certain 120-count bottles. The smell is linked to low levels of two chemicals that aren't expected to cause a safety risk except in people with sickle cell disease.

The bottles will be pulled from pharmacies and wholesalers, and to ensure ongoing supplies of Xeloda, the company will sell blister-packaged tablets imported from the U.K. Previously, Johnson & Johnson pulled some consumer drugs on odor problems, but it was a musty, moldy smell that touched off that recall.

- get the release from FDA
- see the letter from Genentech
- read the Reuters news

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