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. Instead of sodium tablets, some bottles contain Potassium Tablets, which can be harmful to some people, including pregnant women.
The voluntary recall is for 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.
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
To date, Camber has not received adverse event reports associated with this recall.
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