Nearly 370,000 bottles of the popular antidepressant Duloxetine have been recalled as they contain high levels of cancer-causing compounds. This prescription medicine is used to treat depression, anxiety, and nerve damage. In an alert, the US Food and Drug Administration (FDA) said that the medication may contain a carcinogen above the recommended interim limit. The FDA gave the recall the second-highest risk level, Class II. Here’s everything you need to know about the recall.
What is the recalled product?
Breckenridge Pharmaceutical, Inc. has recalled two doses of prescription-only Duloxetine, a commonly prescribed medication belonging to a class of drugs known as serotonin–norepinephrine reuptake inhibitors (SNRIs). These pills are used to treat depression, anxiety, and fibromyalgia, according to the Cleveland Clinic.
Why is the product recalled?
The manufacturer recalled the medication on 4 June after discovering that certain batches contained the “presence of N-nitroso-duloxetine impurity above FDA recommended interim limit”. This contaminant is ‘suspected of causing cancer’, according to the National Library of Medicine. ‘Toxic if swallowed,’ it says.The California State Board of Pharmacy, however, says the exposure does not immediately cause cancer. “Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” it says.The FDA has given a Class II recall, which means it is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” This is the second most serious classification of recall.
How to identify the recalled medication?
If you currently take Duloxetine, check your medication bottle for product information. The recall applies to specific batches distributed by Breckenridge Pharmaceutical. Look for the details.Duloxetine Delayed-Release Capsules, USP, 30 mg
- Size: 1,000 capsules
- Expiration date: April 2027, with lot code: 241180C
- Affected quantity: 14,729 bottles
Duloxetine Delayed-Release Capsules, USP, 60 mg
- Sizes: 90 capsules and 1,000 capsules
- Expiration date: November 2026, with lot code: 232311
- Expiration date: January 2027, with lot code: 240316
- Expiration date: February 2027, with lot codes: 240317, 240318, 240315C, 240373C, 240370C, 240375C, and 240413C
- Expiration date: April 2027, with lot codes: 240978C and 241052C
- Expiration date: May 2027, with lot code: 241074C
- Affected quantity: 359,676 bottles
The distributor said it was ‘not aware of reports of adverse events that have been assessed to be related to this recall,’ the California State Board of Pharmacy said.
What to do if you have the recalled medication?
If you have the recalled medication, talk to your doctor or pharmacist. Ask about the best course of action. Do not panic or discontinue your medication without professional guidance. Stopping antidepressants suddenly can cause withdrawal symptoms and medical complications.
