FDA recalls 233,000 bottles of NJ drug for cancer risk

💊 Drug company in East Brunswick issues recall

💊 Chemical linked to cancer detected in antidepressant

💊 Could be found in other medications

EAST BRUNSWICK — A New Jersey pharmaceutical company is recalling more than 230,000 bottles of antidepressants after detecting a chemical that can cause cancer.

The recall impacts duloxetine sold by Rising Pharmaceuticals. Duloxetine is a delayed-release medication that is often prescribed to treat depression and generalized anxiety disorder.

Headquartered in East Brunswick, Rising Pharmaceuticals issued the voluntary recall on Nov. 19.

However, it was only earlier this month that the U.S. Food and Drug Administration classified it as a Class Two recall — that means exposure to the recalled medication may cause "temporary or medically reversible" health effects.

According to the FDA, the "presence" of a cancer-causing chemical was found in the pills.

What cancer chemical was detected?

The FDA said that nitrosamine impurities (N-nitroso-duloxetine) above acceptable intake levels had been detected in the medication.

Nitrosamines are organic compounds found in low levels in food and water. People who take drugs with acceptable levels of these chemicals are not at higher risk of cancer.

But in higher concentrations, nitrosamines have been linked to a significant increase in the risk of developing cancers.

The recall includes the following bottles of duloxetine DR Capsules USP 60 mg:

🔴 30 count (NDC 57237-019-30)

🔴 90 count (NDC 57237-019-90)

🔴 1000 count (NDC 57237-019-99)

Other medications could be at risk

The FDA recently issued new guidance to drug manufacturers about nitrosamines. This has resulted in several other recalls.

In October, more than 7,000 bottles of other duloxetine antidepressants manufactured by Towa Pharmaceutical Europe were recalled.

SEE ALSO: NJ ‘drone plan of action’ calls for feds’ reaper drones to help

Anyone concerned about whether their medication has been recalled can contact their pharmacist or the FDA’s Division of Drug Information.

The DDI can answer most drug questions. They are reachable by phone at 1-855-543-DRUG (3784).

Report a correction 👈 | 👉 Contact our newsroom