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The FDA is notifying the public that Camber Pharmaceuticals, Inc is voluntarily recalling montelukast tablets due to mislabeling concerns. This recall affects one lot of montelukast 10 mg 30-count bottle (NDC 31722-726-30; Lot MON17384). The bottle may contain 90 tablets of losartan 50 mg instead of 30 tablets of montelukast 10 mg. Montelukast is a leukotriene receptor antagonist that is prescribed for allergies and asthma. It is used to prevent wheezing, chest tightness, coughing, and bronchospasm. The montelukast tablets are round and beige with “114” imprinted on one side and “I” on the other side. Losartan is a medication used to treat high blood pressure. The losartan tablets are oval and white with “5” imprinted on one side and “I” on the other side.
Unintentional exposure to losartan can reduce blood pressure, elevate potassium levels, and impair renal function. Losartan also has the potential to cause harm or death to a developing fetus, so pregnant women are at higher risk if they are exposed to losartan.
Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting Program online at: www.fda.gov/medwatch/report.htm
Additional Information:
- Camber Pharmaceuticals, Inc Press Release – August 31, 2018
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619174.htm