Leiters Health has recalled 33 lots of IV bags filled with vancomycin, phenylephrine and fentanyl because the solutions might contain double the amount labeled.
The drugmaker's semi-automated IV bag filling equipment could fill the bags twice when compressed air tanks become low or a leak happens, the FDA said in a Jan. 8 post. The drugs were distributed to hospitals, and Leiters is asking customers to return the product.
A double dose of vancomycin can cause low blood pressure, shock and cardiac arrest, and overdosing on the antibiotic can lead to acute kidney injury and ototoxicity. A high dose of fentanyl can result in profound respiratory depression or "serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death," the FDA said. For phenylephrine, the risk is "higher-than-intended blood pressures in some patients."
Leiters has not received any adverse event reports related to the superpotency risk.