IV Antibiotic Under Class I Recall

An equipment malfunction that may have led to drug superpotency has prompted Denver Solutions, which does business as Leiters Health, to recall approximately 17,000 bags of intravenous (IV) vancomycin hydrochloride, according to the February 7, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The FDA has designated the recall Class I. The most serious recall designation, the classification warns use of the product could cause serious adverse health consequences or death.

“The recalled batches … may contain twice the labeled amount of drug,” Leiters Health stated in a January 5, 2024, announcement. “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 recall affects the following vancomycin hydrochloride products, which were distributed to hospitals throughout the United States:

• vancomycin HCl PF, 1.25 g added to 0.9% sodium chloride 250 mL, item F3206 (NDC 71449-028-68), from lots 2331184 (Exp. 2/13/24), 2331185 (Exp. 2/10/24), 2331189 (Exp. 2/20/24), 2331191 (Exp. 2/24/24), 2331258 (Exp. 3/3/24), and 2331317 (Exp. 3/15/24); and
• vancomycin HCl PF, 1.5 g added to 0.9% sodium chloride 250 mL, item F3208 (NDC 71449-029-68), from lots 2331140 (Exp. 2/8/24), 2331188 (Exp. 2/15/24), 2331261 (Exp. 3/5/24), and 2331287 (Exp. 3/14/24).

Leiters Health voluntarily initiated the recall December 28, 2023. The FDA issued its Class I designation January 29, 2024.

IV vancomycin is used in hospital settings for endocarditis and staphylococcal infections.