Recall of Montelukast Sodium Tablets

PUBLISHED: Sep 4, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Pharmacy, Rural Health Clinics

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

This tablet mix-up may pose a safety risk as 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. The FDA recommends that consumers who have this recalled product should contact their health care provider or pharmacist immediately.

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

Patients should contact their health care provider or pharmacist to determine if their medicine has been recalled. Patients should also look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

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.

Recalled lots of montelukast sodium tablets, USP 10mg have the following information:

  • Label: Montelukast Sodium Tablets 10 mg 30 ct
  • Lot number: MON17384
  • Expiration date: 12/31/2019
  • NDC: 31722-726-30

For more information, follow the link below.

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