Asthma Drug Montelukast Recalled Due to Medication Mix-Up

Camber Pharmaceuticals has issued a voluntary recall of one lot of montelukast (Singulair), used to treat symptoms of asthma, due to a medication mix-up. According to the FDA, the bottles labelled “montelukast sodium tablets, 10 mg” were found to instead contain 50 mg tablets of the blood pressure drug, losartan.

What is montelukast for?

Montelukast is the generic version of Singulair, and is used to prevent and treat asthma and exercise-induced bronchoconstriction, and relieve symptoms of allergic rhinitis. It is a leukotriene blocker, which means it stops leukotrienes, pro-inflammatory chemicals in the body, from causing inflammation in the lungs and nose and tightening the airways.

Why was montelukast recalled?

Camber Pharmaceuticals has voluntarily recalled one lot of montelukast because they found that the sealed bottles contained losartan, a popular drug used to treat high blood pressure. This is dangerous, as taking losartan instead of montelukast can result in kidney dysfunction, low blood pressure and increased potassium levels. This recall is especially important for pregnant women, since taking losartan can result in fetal harm or even death.

Camber Pharmaceuticals has not received any adverse event reports due to this recall yet.

This hasn’t been Camber’s only medication recall this year. On August 8th the FDA recalled Camber’s popular blood pressure medication valsartan due to concerns over contamination. Apparently, the FDA found NDMA (n-nitrosodimethylamine), a substance that potentially causes cancer, inside some valsartan tablets. Since August 8th, the FDA has expanded the list of recalled valsartan products to include over 10 manufacturers.

According to the FDA, these two recalls are not related even though they involve Camber Pharmaceuticals.

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Which products were recalled?

Currently, only one lot of montelukast was affected:

• Drug: montelukast 10 mg

• Manufacturer: Camber Pharmaceuticals

• Lot: MON17384 (Expiration date: 12/31/2019)

• NDC (National Drug Code): 31722-726-30

What do I do If I think I have a recalled product?

Contact your doctor or healthcare provider if you believe you have a recalled product. They will work with your pharmacist to get you a prescription for montelukast that has not been affected by the recall.

Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.

Why trust our experts?

Written by:

Ronilee Shye, PharmD, BCGP, BCACP, CDE

Roni is an expert in clinical pharmacy and patient care. She received her doctorate in pharmacy from Duquesne University in Pittsburgh, Pennsylvania; is board-certified in geriatrics and ambulatory care pharmacy; and is licensed to practice pharmacy in Ohio, Pennsylvania, and Florida.

Edited by:

Tori Marsh, MPH

Tori Marsh is GoodRx’s resident expert on prescription drug pricing, prescribing trends, and drug savings. She oversees the GoodRx drug database, ensuring that all drug information is accurate and up to date.

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