Possible Label Switch Prompts Pfizer Recall
http://www.medpagetoday.com/ProductAlert/Prescriptions/25560
A possible label switch affecting an antidepressant and a drug used to shrink the prostate prompted a Pfizer subsidiary to recall both drugs.
The affected drugs -- both generic formulations -- are citalopram, an antidepressant, and finasteride, which is used to treat benign prostatic hyperplasia.
"Bottles labeled as citalopram Lot # FI0510058-A may contain finasteride," according to an announcement from Greenstone LLC, the Pfizer unit selling the products.
The company said the recall stemmed from "the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer." It said only the one lot was affected.
Patients with bottles of either drug with this lot number on the label should return the products to the pharmacy, the company said.
The lot number involves citalopram in 100-count bottles of 10-mg tablets and finasteride in 90-count bottles of 5-mg tablets.
Patients taking the wrong medications may be at risk for serious adverse effects, Greenstone stressed.
"Women who are, or may become pregnant, should not take or handle finasteride due to the possible risk of... abnormalities to the external genitalia of a developing male fetus," the company noted.
Moreover, patients who discontinue citalopram abruptly by inadvertently taking the mislabeled product may experience withdrawal symptoms and/or worsening depression.
Greenstone also indicated that some finasteride-labeled bottles may contain the antidepressant. It warned that citalopram is contraindicated in patients taking monoamine oxidase inhibitors or pimozide because of adverse effects associated with the combination
http://www.medpagetoday.com/ProductAlert/Prescriptions/25560
A possible label switch affecting an antidepressant and a drug used to shrink the prostate prompted a Pfizer subsidiary to recall both drugs.
The affected drugs -- both generic formulations -- are citalopram, an antidepressant, and finasteride, which is used to treat benign prostatic hyperplasia.
"Bottles labeled as citalopram Lot # FI0510058-A may contain finasteride," according to an announcement from Greenstone LLC, the Pfizer unit selling the products.
The company said the recall stemmed from "the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer." It said only the one lot was affected.
Patients with bottles of either drug with this lot number on the label should return the products to the pharmacy, the company said.
The lot number involves citalopram in 100-count bottles of 10-mg tablets and finasteride in 90-count bottles of 5-mg tablets.
Patients taking the wrong medications may be at risk for serious adverse effects, Greenstone stressed.
"Women who are, or may become pregnant, should not take or handle finasteride due to the possible risk of... abnormalities to the external genitalia of a developing male fetus," the company noted.
Moreover, patients who discontinue citalopram abruptly by inadvertently taking the mislabeled product may experience withdrawal symptoms and/or worsening depression.
Greenstone also indicated that some finasteride-labeled bottles may contain the antidepressant. It warned that citalopram is contraindicated in patients taking monoamine oxidase inhibitors or pimozide because of adverse effects associated with the combination
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