Superpotency concerns spur recall of IV bags for vancomycin, phenylephrine, and fentanyl

Editor's Note: 

Englewood, Colo,-based Leiters Health is voluntarily recalling 33 lots of vancomycin, phenylephrine, and fentanyl IV bags due to concerns that they may contain twice the labeled amount of drug, according to a January 8 safety alert from the US Food and Drug Administration (FDA).

“The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice,” the company’s announcement reads. “There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events.”

To date, Leiters Health has not received any reports of adverse events related to this recall.