FDA Recalls 3 IV Drugs from Leiters Health for Potential Superpotency

On January 5, 2024, the United States FDA published an announcement detailing a voluntary recall of multiple intravenous (IV) drugs manufactured by Leiters Health. The release notes that 33 lots of IV bags, including vancomycin, phenylephrine, and fentanyl IV bags, have been recalled due to potential superpotency.

The recalled compounds and corresponding lot numbers are listed below:

• FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag: 2331062, 2331224, and 2331270
• FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag: 233098, 2331058, 2331150, 2331231, and 2331289
• Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag: 2330993, 2331010, 2331055, 2331055, 2331113, 233118, 2331187, 2331266, 2331343, 2331343, 2331349, and 2331433
• Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag: 2330939, 2331032, 2331112, 2331190, and 2331429
• Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL IV Bag: 2331184, 2331185, 2331189, 2331191, 2331258, and 2331317
• Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL IV Bag: 2331140, 2331188, 2331261, and 2331287

According to the press release, these IV bags are filled through a semi-automated process; however, the filling equipment may not have properly ejected the IV bags when they should have been. Some cases that warrant ejecting the bags are a low-level compressed air tank or a leak.

Failure to eject the bags under these conditions may have caused the filling equipment to dose each bag twice, yielding potential risks to the patients prescribed these medications.

In some cases, using the defective IV bags can be fatal to patients. For example, fentanyl is a synthetic opioid that is used for pain management in severe cases, such as advanced cancer pain. The CDC notes that fentanyl is 50 times stronger than heroin and 100 times stronger than morphine. If given too much fentanyl, like any opioid, patients can overdose and eventually die. While fentanyl dosing by providers is carefully calculated to minimize the risk of overdose, inappropriately filled IV bags may contradict these calculations.

Beyond the risks associated with fentanyl, a high dose of vancomycin, an antibiotic often used to treat Staphylococcus aureus, may also put patients at risk. An article published in Clinical and Experimental Pharmacology and Physiology revealed that the overuse of vancomycin may be linked to nephrotoxicity and antibiotic resistance.

Although Leiters Health maintains that no adverse events have been reported, healthcare facilities should review their drug supply and dispose of the affected lots.