Baxter International ($BAX) is again recalling a potassium chloride product, but this time, instead of particulate contamination, it is because another product was mistakenly mixed in the shipment.
According to an FDA MedWatch notice, Baxter is voluntarily recalling one lot of potassium chloride injection 10mEq per 100mL because of a labeling error on the shipping cartons, which was uncovered by three different customers. The company said shipping cartons which are labeled as potassium chloride injection may contain units of gentamicin sulfate injection, 80 mg in 100 mL.
Potassium chloride is used to treat potassium deficiency, while gentamicin sulfate is an antibacterial drug. In one scenario, someone needing potassium chloride might not receive it, while in another there is a chance for a medical error if gentamicin is given to the wrong patient. Gentamicin can cause severe hearing and kidney problems. The company said so far there have been no reports of adverse events.
Baxter has had a series of recalls of late. In July, the company initiated a worldwide recall of three lots of sodium chloride as well as one of highly concentrated potassium chloride. The recall of the saline came even as hospitals for months have been facing a shortage of the essential product. Because they were small volume products, Baxter said the recall should not have much impact on the shortage. Then in August, the Deerfield, IL-based company recalled one lot of large-volume sodium chloride bags in the U.S. because of contamination.
In March, the company recalled a single lot of a peritoneal product used on dialysis patients which had been contaminated with mold. In that case, the company acknowledged there had been three reported adverse reactions.
- here's the FDA MedWatch notice