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For the second time in four months, Baxter International finds itself recalling highly concentrated potassium chloride. This time its a labeling problem, one that the company says has the potential to be life-threatening.
Baxter ($BAX) issued the voluntary recall of one lot to the consumer level after a complaint that the overpouch of some 10 milliequivalents per 100 mL product was labeled as 20 milliequivalents per 100 mL. The problem, as Baxter points out in its recall, is that patients may not get the right dose. That can be serious for patients in the high-risk category who are "prone to severe electrolyte imbalance." So far, no adverse events have been reported, Baxter said.
Baxter has had a series of recalls of its injected and infused products this year for a variety or reasons. In July the drugmaker initiated a voluntary global recall of one lot of the highly concentrated solution, 20 milliequivalents per 50 mL of product. That time it was because of complaints of particulate in some bags. In September, the company recalled one lot of potassium chloride injection 10 mEq per 100 mL after receiving at least three complaints that some shipping cartons contained units of the antibacterial drug gentamicin sulfate injection.
Early this year, the company received reports that some patients had reacted adversely after receiving a peritoneal product used on dialysis patients that was contaminated with mold.
- here's the recall notice