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Asthma Drug Recall; Incorrect Blood Pressure Drug in Bottles


On August 31, 2018, the FDA warned consumers and health care professionals about a recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019, NDC: 31722-726-30 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

 

This tablet error may pose a safety risk because taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels, and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus.

 

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

 

“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. “Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed.”

 

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma. It is also used to prevent bronchospasm (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. Losartan is also used to decrease the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy (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.

 

See the Recall

 

See also Medical Law Perspectives Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability Risks

 

See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives Report: Asthma Risks and Liabilities: Taking a Deep Breath

 

 

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