Asthma Medicine Recalled Due to Tablet Mix-Up That May Pose Safety Risk

The risk of unintentional consumption of losartan tablets is particular high for pregnant women, as the treatment could harm the fetus.
The risk of unintentional consumption of losartan tablets is particular high for pregnant women, as the treatment could harm the fetus.

Camber Pharmaceuticals is recalling one lot of Montelukast Sodium Tablets as the lot was found to contain Losartan Potassium Tablets instead. 

The affected product has the Lot #MON17384 and an expiration date of 12/31/2019. The label on the sealed bottle states 'Montelukast Sodium Tablets, 10 milligram' containing 20 tablets but actually contains 90 Losartan Potassium Tablets, 50mg. 

Taking losartan when not prescribed may cause renal dysfunction, hyperkalemia, and hypotension. Additionally, the risk of mixing-up the medications is especially high for pregnant women, as losartan is indicated to treat high blood pressure and could harm or kill a fetus. 

Montelukast, a luekotriene receptor antagonist, is used to prevent asthma symptoms such as wheezing, difficulty breathing, chest tightness and coughing; it is also indicatd to treat symptoms of seasonal and perennial allergic rhinitis. Losartan, an angiotensin II receptor blocker (ARB), is used alone or in combination with other drugs to treat hypertension and to reduce the risk of stroke in patients with high blood pressure and left ventricular hypertrophy.

The FDA recommends that consumers who have this recalled product should contact their healthcare provider or pharmacist immediately. 

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Montelukast sodium tablets are beige, rounded square-shaped, film coated tablets with “I” imprinted on 1 side and “114” on the reverse. Losartan tablets are white and oval-shaped with the letter “I” imprinted on 1 side and the number “5” imprinted on the reverse. 

For more information visit FDA.gov.