Medications & Supplements/Prescription Drugs

Leiters Health Oxytocin and Vancomycin IV Bags Recalled for Labeling Errors

Agency Publication Date: October 26, 2023

Summary

Denver Solutions, LLC, doing business as Leiters Health, is recalling 65,664 units of Oxytocin and Vancomycin IV bags due to labeling errors. The recall includes Oxytocin (synthetic) 500mL IV bags and Vancomycin HCl PF IV bags in both 1.25g and 1.5g strengths. These products were distributed to hospital pharmacies and through Leiters Compounding Health nationwide. No incidents or injuries have been reported to date, but incorrect labeling can lead to medication errors.

Risk

Labeling errors can cause healthcare providers to administer the wrong medication or the wrong dosage to a patient. This poses a risk of adverse health consequences depending on the medication delivered and the patient's condition.

What You Should Do

This recall affects Oxytocin (synthetic) 500mL IV bags (NDC 71449-157-70) and Vancomycin HCl PF 250mL IV bags (NDC 71449-028-68 and 71449-029-68) sold under the Leiters Compounding Health brand.
Check the NDC number, lot number, and expiration date on the IV bag label to determine if your product is affected. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately. Contact Leiters Health or your distributor to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL)

Variants: 500mL IV Bag, 0.06 Units per mL

Lot Numbers:

2330956 (Exp. 10/23/2023)

2330964 (Exp. 10/24/2023)

2331014 (Exp. 11/6/2023)

2331033 (Exp. 11/8/2023)

NDC:

71449-157-70

Rx only, Leiter Compounding Health.

Product: VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag

Variants: 250 mL IV Bag, 1.25 g

Lot Numbers:

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 (Exp. 10/20/23)

2330897 (Exp. 11/23/23)

2330899 (Exp. 11/25/23)

2330901 (Exp. 11/26/23)

2330918 (Exp. 11/30/23)

2330943 (Exp. 01/12/24)

2331050 (Exp. 01/14/24)

2331064 (Exp. 01/21/24)

2331102 (Exp. 01/25/24)

NDC:

71449-028-68

Rx only, Leiter Compounding Health.

Product: VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag

Variants: 250 mL IV Bag, 1.5 g

Lot Numbers:

2330792 (Exp. 12/17/23)

2330801 (Exp. 12/26/23)

2330821 (Exp. 10/15/23)

2330823 (Exp. 10/21/23)

2330825 (Exp. 10/27/23)

2330846 (Exp. 10/28/23)

2330847 (Exp. 11/03/23)

2330856 (Exp. 11/17/23)

2330858 (Exp. 12/03/23)

2330860 (Exp. 12/15/23)

2330866 (Exp. 12/29/23)

2331053 (Exp. 01/13/24)

NDC:

71449-029-68

Rx only, Leiter Compounding Health.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93178

Status: Resolved

Manufacturer: Denver Solutions, LLC DBA Leiters Health

Sold By: Hospital pharmacies; Leiters Compounding Health

Manufactured In: United States

Units Affected: 3 products (6,276 IV bags; 33,480 IV Bags; 25,908 IV bags)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Oxytocin (synthetic) 500mL IV bags (NDC 71449-157-70) and Vancomycin HCl PF 250mL IV bags (NDC 71449-028-68 and 71449-029-68) sold under the Leiters Compounding Health brand.

Check the NDC number, lot number, and expiration date on the IV bag label to determine if your product is affected. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately. Contact Leiters Health or your distributor to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL)

Variants: 500mL IV Bag, 0.06 Units per mL

Lot Numbers:

2330956 (Exp. 10/23/2023)

2330964 (Exp. 10/24/2023)

2331014 (Exp. 11/6/2023)

2331033 (Exp. 11/8/2023)

NDC:

71449-157-70

Rx only, Leiter Compounding Health.

Product: VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag

Variants: 250 mL IV Bag, 1.25 g

Lot Numbers:

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 (Exp. 10/20/23)

2330897 (Exp. 11/23/23)

2330899 (Exp. 11/25/23)

2330901 (Exp. 11/26/23)

2330918 (Exp. 11/30/23)

2330943 (Exp. 01/12/24)

2331050 (Exp. 01/14/24)

2331064 (Exp. 01/21/24)

2331102 (Exp. 01/25/24)

NDC:

71449-028-68

Rx only, Leiter Compounding Health.

Product: VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag

Variants: 250 mL IV Bag, 1.5 g

Lot Numbers:

2330792 (Exp. 12/17/23)

2330801 (Exp. 12/26/23)

2330821 (Exp. 10/15/23)

2330823 (Exp. 10/21/23)

2330825 (Exp. 10/27/23)

2330846 (Exp. 10/28/23)

2330847 (Exp. 11/03/23)

2330856 (Exp. 11/17/23)

2330858 (Exp. 12/03/23)

2330860 (Exp. 12/15/23)

2330866 (Exp. 12/29/23)

2331053 (Exp. 01/13/24)

NDC:

71449-029-68

Rx only, Leiter Compounding Health.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93178

Status: Resolved

Manufacturer: Denver Solutions, LLC DBA Leiters Health

Sold By: Hospital pharmacies; Leiters Compounding Health

Manufactured In: United States

Units Affected: 3 products (6,276 IV bags; 33,480 IV Bags; 25,908 IV bags)

Distributed To: Nationwide