The US Food and Drug Administration (FDA) stated that Camber Pharmaceuticals has issued a voluntary recall, after packaging the wrong medication into bottles that were issued to health care providers and pharmacists.
A lot of 10mg montelukast sodium tablets (lot number MON17384, with an expiration date of 31/12/2019) was found to actually contain losartan potassium tablets, 50mg.
The mistake could adversely impact patients’ health, as the FDA’s notice identified a risk of developing renal dysfunction, elevated potassium levels and low blood pressure in those unknowingly taking losartan. Losartan tablets are used to treat high blood pressure, which means certain population groups are particularly at risk, such as pregnant women.
“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”, stressed Donald D. Ashley, director of the office of compliance in the FDA’s center for drug evaluation and research.
Montelukast is used to prevent symptoms of asthma, including wheezing, difficulty breathing and coughing.
The FDA noted that Camber had not received any notices regarding adverse events associated with the lot of medicine.
At the time of publishing, Camber had not replied to a request for comment.
More bad news
The news is the second announcement in a short time for Camber relating to drug safety, as the company was also drawn into an on-going investigation into impurities discovered within certain valsartan medications.
The valsartan investigation continues to broaden, after Chinese companies providing the active pharmaceutical ingredient (API) involved were found to have inadvertently introduced a probable carcinogen.
Camber’s portfolio of medicines includes valsartan and it announced a recall at the end of last month.
