Leiters Health Recalls VANCOmycin IV Bags Due to Double Dose Risk
Leiters Health recalls specific VANCOmycin HCl PF 1.25g IV bags for possible double dosing risk. Affected units have unique lot numbers and expiration dates. Stop using immediately if you own these bags.
Stop using this now
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
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What happened, in plain English
Leiters Health is recalling certain VANCOmycin HCl PF 1.25g IV bags that may contain a double dose of medication due to a malfunction in their filling system. This could lead to an overdose if used in medical treatment. Read more at govinfonow.com/recall/32898-leiters-health-recalls-vancomycin-iv-bags-due-to-double-dose.
Source Summary by GovInfoNow · govinfonow.com/recall/32898-leiters-health-recalls-vancomycin-iv-bags-due-to-double-dose · Updated August 17, 2026 · FDA enforcement record: FDA #D-0281-2024
Cite this page
“Leiters Health Recalls VANCOmycin IV Bags Due to Double Dose Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32898-leiters-health-recalls-vancomycin-iv-bags-due-to-double-dose. Based on FDA recall #D-0281-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0281-2024%22&limit=1).
Why it’s dangerous
The semi-automated IV bag filling system can malfunction and deliver double the intended dose of VANCOmycin HCl PF. This could cause serious harm or death if administered to patients.
Who’s affected
Healthcare professionals and hospitals that use these specific IV bags for patient treatment. Patients receiving IV medication from these bags are at risk of overdose.
How to tell if you have this one
Check for the lot numbers: 2331184 (exp. 02/13/2024), 2331185 (exp. 02/10/2024), 2331189 (exp. 02/20/2024), 2331191 (exp. 02/24/2024), 2331258 (exp. 03/03/2024), or 2331317 (exp. 03/15/2024). The product is labeled as VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206.
- Brand
Leiters Health- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0277-2024 | FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.; Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024. | 8,976 IV bags |
| D-0278-2024 | FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.; Lot #: 2330988, Exp. Date 01/31/2024; 2331058, Exp. Date 02/18/2024; 2331150, Exp. Date 03/10/2024; 2331231, Exp. Date 03/24/2024; 2331289, Exp. Date 03/30/2024. | 13,920 IV bags |
| D-0279-2024 | PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.; Lot #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024. | 29,016 IV bags |
| D-0280-2024 | PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.; Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024. | 12,564 IV bags |
| D-0281-2024 | VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.; Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024. | 10,152 IV bags |
| D-0282-2024 | VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.; Lot #: 2331140, Exp. Date 02/08/2024; 2331188, Exp. Date 02/15/2024; 2331261, Exp. Date 03/05/2024; 2331287, Exp. Date 03/14/2024. | 7,548 IV bags |
What to do — step by step
Stop Using Immediately
Discontinue use of the recalled IV bags if you have them. Do not administer to patients.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0281-2024 (December 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0281-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.