Camber Pharmaceuticals announced that its 30-count bottle of Montelukast Sodium Tablets contained 90 tablets of 50 mg Losartan Potassium Tablets. The mix-up could cause a health and safety risk such as renal dysfunction, elevated potassium levels and low blood pressure to an unsuspecting patient.
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.
Pregnant women taking motelukast for asthma or allergies are at an especially high risk because losartan, used to treat high blood pressure, could harm or kill the fetus.
The U.S. Food and Drug Administration issued the voluntary recall last week in a press announcement. “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 J.D., director of the office of compliance in the FDA’s center for drug evaluation and research.
Montelukast is considered a leukotriene receptor antagonist (LTRAs). They work by blocking substances in the body that trigger allergies and rhinitus. It is used to treat asthma, prevent bronchospasm (breathing difficulties) or seasonal and perennial allergic rhinitus. Montelukast helps prevent wheezing, chest tightness, and coughing in the patient.
Losartan, on the other hand, is used to treat high blood pressure. It can be used individually or in combination with other medications. It is also used to decrease the risk of stroke and left ventricular hypertrophy (an enlargement of the walls on the left side of the heart).
Patients are urged to double-check their prescription drug name and company name on the label or their prescription bottle.
The recalled lots of montelukast sodium tablets are white, round square-shaped with an imprinted “I” on one side and “114” imprinted on the other. Losartan tablets are white and oval shaped imprinted with “I” on one side and “5” on the other.
The recalled lots of 10mg montelukast tablets are MON17384 with an expiration date of 12/31/2019. NDC number appears as 31722-726-30.