Superpotency Concerns Prompt Recall of IV Hypotension Drug

The US Food and Drug Administration (FDA) has issued a Class I designation for the recall of more than 41,000 bags of intravenous (IV) phenylephrine hydrochloride from Leiters Health, according to the February 7, 2024, FDA Enforcement Report. The most serious recall categorization possible, a Class I designation warns use of the recalled product could cause serious adverse health consequences or death.

The recalled phenylephrine IV bags may contain twice the labeled amount of the drug. Recalling firm Denver Solutions, which does business as Leiters Health, cited a problem with semi-automated IV bag filling equipment in a company announcement.

“[A]dministration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients,” the company explained in the January 5, 2024, statement. “To date, Leiters Health has not received any reports of adverse events related to this recall.”

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

• phenylephrine HCl, 20 mg per 250 mL 0.9% sodium chloride (80 mcg per mL), item F3360 (NDC 71449-148-94), from lots 2330993 (Exp. 2/15/24), 2331010 (Exp. 2/10/24), 2331055 (Exp. 1/18/24), 2331113 (Exp. 2/26/24), 2331181 (Exp. 3/4/24), 2331187 (Exp. 3/23/24), 2331266 (Exp. 3/31/24), 2331343 (Exp. 4/1/24), 2331349 (Exp. 4/23/24), and 2331433 (Exp. 5/5/24); and
• phenylephrine HCl, 40 mg per 250 mL 0.9% sodium chloride (160 mcg per mL), item F3352 (NDC 71449-150-82), from lots 2330939 (Exp. 1/30/24), 2331032 (Exp. 2/3/24), 2331112 (Exp. 3/19/24), 2331190 (Exp. 3/26/24), and 2331429 (Exp. 4/28/24).

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

IV phenylephrine is used in hospital settings for perioperative hypotension, hypotension during anesthesia, and shock.