FDA announces voluntary recall of montelukast tablets by Camber Pharmaceuticals
FDA reported Friday that Camber Pharmaceuticals has launched a voluntary recall of one lot of montelukast sodium tablets, as the bottles were found to contain the wrong drug.
FDA reported Friday that Camber Pharmaceuticals has launched a voluntary recall of one lot of montelukast sodium tablets, as the bottles were found to contain the wrong drug. In the affected lot, sealed bottles labeled as montelukast sodium tablets, 10 mg, 30-count bottle, were found to contain 90 tablets of losartan potassium tablets, 50 mg, instead. According to FDA, "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." Camber has not received any adverse event reports associated with this recall so far. However, FDA advised consumers who have the recalled product to contact their health care provider or pharmacist at once. "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, JD, director of the office of compliance in FDA's Center for Drug Evaluation and Research. "Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed." The affected lot from Camber is MON17384, with an expiration date of December 31, 2019. 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.