Citalopram, irinotecan hydrochloride recalled

April 5, 2011

APP Pharmaceuticals Inc. in Schaumburg, Ill., recently recalled 5 lots of irinotecan hydrochloride injection, used to treat recurrent or progressive metastatic colorectal cancer. Greenstone LLC has recalled 1 lot of Citalopram, used to treat depression, because the bottles may contain finasteride.

APP Pharmaceuticals Inc. in Schaumburg, Ill., recently recalled 5 lots of irinotecan hydrochloride injection, used to treat recurrent or progressive metastatic colorectal cancer.

Meanwhile, APP is recalling certain lots of irinotecan hydrochloride injection because 3 customers complained about particulates in 1 of the lots. The particulate was confirmed to be a fungal microbial contaminant, according to APP. “Non-sterility of a chemotherapeutic products administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised,” said a statement released by APP.

The recalled lots of irinotecan hydrochloride include 870DE00301, 870CZ00301, 870DE00101, 870DE00201, and 870DE00401. The doses include 100 mg/5 mL, 40 mg/ 2 mL, 2 mL single dose, and 5 mL single dose.

Greenstone LLC has recalled 1 lot of citalopram, used to treat depression, because the bottles may contain finasteride. A third-party manufacturer may have placed the incorrect labels on the citalopram bottles.

The recall affects lot number FI0510058-A, citalopram 10 mg tablets (100-count bottle) and finasteride 5 mg tablets (90-count bottle). Both products are distributed in the United States.

Women who are pregnant or who may become pregnant should not take finasteride, which is used to treat benign prostatic hyperplasia.

Citalopram is contraindicated in patients taking monoamine oxidase inhibitors or primozide, as well as those with a hypersensitivity to citalopram or its inactive ingredients.