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Unrated Drug recall · FDA · Published October 4, 2023

Leiters Health Recalls VANCOmycin HCI PF IV Bags for Labeling Issue

Leiters Health recalls specific VANCOmycin HCI PF IV bags due to labeling concerns. This is a drug product for medical use only.

🇺🇸 FDA recall #D-0071-2024DrugLeiters Health ›
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Recalling firmDenver Solutions, LLC DBA Leiters Health13796 Compark Blvd · Englewood, CO 80112-7145
✎ GovInfoNow plain-language explainer

What happened, in plain English

Leiters Health has recalled certain VANCOmycin HCI PF IV bags that were compounded with 0.9% Sodium Chloride. The recall is due to labeling issues that could affect safe medical use. Read more at govinfonow.com/recall/33064-leiters-health-recalls-vancomycin-hci-pf-iv-bags-for-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/33064-leiters-health-recalls-vancomycin-hci-pf-iv-bags-for-labeling · Updated August 17, 2026 · FDA enforcement record: FDA #D-0071-2024

Cite this page

“Leiters Health Recalls VANCOmycin HCI PF IV Bags for Labeling Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33064-leiters-health-recalls-vancomycin-hci-pf-iv-bags-for-labeling. Based on FDA recall #D-0071-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0071-2024%22&limit=1).

Why it’s dangerous

The labeling issue means the product may not be correctly identified or used in medical settings. This could lead to incorrect dosing or administration errors if the bags are not properly labeled.

Who’s affected

Healthcare professionals who use these IV bags for medical treatments are likely affected. Patients receiving this medication through these bags may also be impacted.

How to tell if you have this one

Check for the product name 'VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag' with the specific lot numbers listed in the recall notice.

  • Brand
    Leiters Health
  • Category
    Drug
FDA recall event · 3 products

All 3 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 III
  • Status
    Terminated
  • Distribution
    USA Nationwide
Recall numberProduct, codes & lotsQuantity
D-0070-2024Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70; Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/20236,276 IV bags
D-0071-2024VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.; Lot#: 2330781, Exp. 10/19/23; 2330791, Exp. 10/29/23; 2330795, Exp. 11/02/23; 2330800, Exp. 11/09/23; 2330807, Exp. 11/11/23; 2330812, Exp. 11/16/23; 2330816, Exp. 11/19/23; 2330822, 10/20/23; 2330897,11/23/23; 2330899, 11/25/23; 2330901, 11/26/23; 2330918, 11/30/23; 2330943, 01/12/24; 2331050, 01/14/24; 2331064, 01/21/24; 2331102, Exp. 01/25/24.33,480 IV Bags
D-0072-2024VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.; Lot#: 2330792, Exp. 12/17/23; 2330801, Exp. 12/26/23; 2330821, 10/15/23; 2330823, Exp. 10/21/23; 2330825, Exp. 10/27/23; 2330846, Exp. 10/28/23; 2330847, Exp. 11/03/23; 2330856, 11/17/23; 2330858, Exp. 12/03/23; 2330860, 12/15/23; 2330866, Exp. 12/29/23; 2331053, Exp. 01/13/24.25,908 IV bags
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the lot numbers listed in the recall notice: 2330781 to 2331102.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: Oct 4, 202312. FDA classified it Class III: Oct 26, 202323. Published in FDA’s Enforcement Report: Nov 1, 202334. FDA terminated the recall: Aug 15, 2024420232024
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

How can I find out if I have the recalled product?

Check the product label for the lot numbers: 2330781, 2330791, 2330795, 2330800, 2330807, 2330812, 2330816, 2330822, 2330897, 2330899, 2330901, 2330918, 2330943, 2331050, 2331064, 2331102.

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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-0071-2024 (October 4, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0071-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA