FDA: Mix-up Prompts Montelukast Sodium Tablet Recall

One lot of Montelukast Sodium Tablets (MON17384, expiration 12/31/2019) is being voluntarily recalled by Camber Pharmaceuticals. In a warning to consumers and health care professionals, officials with the FDA said sealed bottles labeled as Camber’s allergy and asthma medication ‘montelukast sodium tablets, 10 milligram, 30-count’ were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. The tablet mix-up may pose a safety risk to consumers.

According to the FDA, patients taking losartan tablets when not prescribed this product are at risk for potential renal dysfunction, elevated potassium levels, and low blood pressure. These risks are especially high for a pregnant woman taking montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus. The FDA is encouraging consumers who possess this recalled product to contact their health care provider or pharmacist immediately.

“We want to ensure that patients who take montelukast are aware of this recall due to the serious risks associated with taking losartan in its place,” said Donald D. Ashley JD, director of the office of compliance in the FDA’s center for drug evaluation and research, in a prepared statement. “Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed.”

To date, Camber has not received adverse event reports associated with this recall, the FDA said, in a statement. The agency encourages health care professionals and consumers to report adverse events to the FDA’s MedWatch Adverse Event Reporting program.

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness and coughing caused by asthma. It is also used to prevent breathing difficulties during exercise and to treat the symptoms of seasonal and perennial allergic rhinitis. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs) which work by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.

Losartan is often used alone or in combination with other medications to treat high blood pressure. The drug is also used to decrease the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy, which is enlargement of the walls of the left side of the heart.

Montelukast sodium tablets are beige, rounded square-shaped, film coated tablets that are imprinted with “I” on one side and “114” on the reverse. Losartan tablets are white and oval-shaped with the letter “I” imprinted on one side and the number “5” imprinted on the reverse.

This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine.

Reference

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles [news release]. Silver Spring, MD; August 31, 2018: FDA website. http://www.pharmacytimes.com/link/215. Accessed August 31, 2018.