Leiters Health recalls specific PHENYLephrine HCl IV bags due to potential double dosing from a semi-automated filling system. Affected lots expire by February 2024.
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Leiters Health is recalling certain PHENYLephrine HCl IV bags that may contain double doses due to a malfunction in their filling system. This could lead to serious overdose risks for patients receiving IV treatments.
The semi-automated IV bag filling system can malfunction and deliver double the intended dose of PHENYLephrine HCl. This risk occurs during the manufacturing process when filling the bags with the drug solution.
Healthcare professionals using these IV bags for medical treatments. Patients receiving IV therapy with the recalled bags are at risk of overdose.
Check for the product name 'PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL)' and the specific lot numbers listed in the recall notice. The product is for IV use only.
If you have the recalled PHENYLephrine HCl IV bags, stop using them right away to prevent potential overdose.
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796.
Affected lots include 2330993 (exp. 02/15/2024), 2331010 (exp. 02/10/2024), 2331055 (exp. 01/18/2024), 2331113 (exp. 02/26/2024), 2331181 (exp. 03/04/2024), 2331187 (exp. 03/23/2024), 2331266 (exp. 03/31/2024), 2331343 (exp. 04/01/2024), 2331349 (exp. 04/23/2024), and 2331433 (exp. 05/05/2024).
Check the lot number on the IV bag. The product is for IV use only and the affected lot numbers are listed in the recall notice.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0279-2024 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0279-2024 from Leiters Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
