Antidepressant recalled: second highest FDA risk level; The drug contains cancer-causing chemicals

According to the FDA, thousands of bottles of antidepressants are being recalled because they contain high levels of cancer-causing chemicals.

The FDA assigned the drug duloxetine extended-release capsules to the second-highest risk level after drug distributor Breckenridge Pharmaceutical Inc. voluntarily issued the recall earlier this month.

A Class II recall represents “a situation in which use of or exposure to an infringing product may cause temporary or medically reversible adverse health effects, or in which the likelihood of serious adverse health effects is remote.”

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The company's recall affects more than 7,000 bottles containing 500 tablets of 20 mg capsules each.

The drug is manufactured by Towa Pharmaceutical Europe and is used to treat depression, anxiety and nerve pain caused by fibromyalgia.

However, routine production inspections detected small amounts of a cancer-causing chemical called N-nitroso-duloxetine, the FDA recall information said.

Although these chemicals are commonly found in water and food, the FDA regulates how much of these chemicals can be contained in certain items because high concentrations can be harmful.

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The California Board of Pharmacy reported earlier this year that it had received notice of the drug recall and urged “pharmacies to immediately review their quality assurance and recall policies and procedures to determine whether corrective action is necessary.” The The Oct. 10 recall is at least the second recall of N-nitroso-duloxetine by Breckenridge Pharmaceutical Inc. this year.

The drug retailer is a US-based subsidiary of Towa Pharmaceutical Europe.

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The company announced a recall back in April because it contained more than acceptable levels of N-Nitroso-Duxentin. According to the FDA's recall information page, the recall involved over half a million bottles of medication.