Class I Recall for IV Analgesic

Nearly 23,000 bags of intravenous (IV) fentanyl citrate from Leiters Health are under a Class I recall for potential superpotency. According to the February 7, 2024, US Food and Drug Administration (FDA) Enforcement Report, the IV bags may contain a double dose.

A Class I recall is the strongest recall designation the FDA can issue. It warns use of the product could cause serious adverse health consequences or death.

“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,” explained recalling firm Denver Solutions, which does business as Leiters Health, in a January 5, 2024, company announcement.

The recall affects the following fentanyl citrate products, which were distributed to hospitals throughout the United States:

• fentanyl citrate PF, 1000 mcg per 100 mL 0.9% sodium chloride (10 mcg per mL), item F3355 (NDC 71449-072-41), from lots 2331062 (Exp. 2/8/24), 2331224 (Exp. 3/18/24), and 2331270 (Exp. 3/28/24); and
• fentanyl citrate PF, 2500 mcg per 250 mL 0.9% sodium chloride (10 mcg per mL), item F3342 (NDC 71449-072-82), from lots 2330988 (Exp. 1/31/24), 2331058 (Exp. 2/18/24), 2331150 (Exp. 3/10/24), 2331231 (Exp. 3/24/24), and 2331289 (Exp. 3/30/24).

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

Fentanyl citrate is an analgesic drug. As of early January, Leiters Health had not received any reports of adverse events related to the recall.