Particles, odors again drive recalls, but origins differ

Cancer treatments, among the highest ranking of drugs in short supply, are now suffering a plague of recalls. Three of the extreme actions were announced last week, triggered by problems that sound similar to those of recent recalls. But last week's actions have largely different origins.

First, Roche's Genentech unit is battling a mothball-like odor and taste in bottled Xeloda tablets. The drugmaker has traced the odor to naphthalene and 1,4-dichlorobenzene. Unlike several high-visibility recalls by J&J's McNeil unit and other drugmakers, consumers are not describing the odor as "musty" or "moldy." And the chemical agent is a disinfectant and pesticide, not an insecticide used on wooden shipping pallets.

To maintain the drug supply, Genentech has arranged with the FDA to temporarily import the drug in blister packs from the UK.

Meanwhile, APP Pharmaceuticals is recalling five lots of colorectal-cancer treatment Irinotecan hydrochloride injection because of foreign material and non-sterility in one lot. Three customers reported the particle contamination. In contrast to recent particle-contamination recalls of injectables traced to glass delamination, the APP contaminant is fungal.

Finally, a mislabeling case involves Pfizer's prostate drug, Finasteride, which may be identified on the bottle as Citalopram (and vice-versa). Cancer sufferers might benefit from the antidepressant, but it's unlikely to cure them. The recall extends to consumers. And it's similar to a recent Mylan recall in which labels for two drugs were co-mingled.

- here's the Pfizer/Greenstone recall notice
- see Genentech's Dear Healthcare Professional letter
- see the APP release