Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Levofloxacin Injection Recalled for Superpotency and High Concentration

Agency Publication Date: September 27, 2018

Summary

Baxter Healthcare Corporation is recalling 523,896 bags of Levofloxacin (levofloxacin) Injection in 5% Dextrose (5 mg/mL) because the medication was found to be superpotent. This means the concentration of the antibiotic is higher than specified, which could result in patients receiving a higher dose of the drug than intended. The recall affects 50 mL, 100 mL, and 150 mL bags distributed across the United States and Puerto Rico. Consumers should contact their healthcare provider or pharmacist for guidance and return any unused product to the pharmacy for a refund.

Risk

A superpotent drug contains a higher concentration of the active ingredient than prescribed, which can lead to an accidental overdose or an increased risk of adverse side effects associated with levofloxacin. While the risk level is categorized as low, receiving an incorrect dosage of prescription medication can cause serious health complications.

What You Should Do

Check your medical records or existing supplies for Levofloxacin Injection in 5% Dextrose (5 mg/mL) in 50 mL (NDC 36000-046-24), 100 mL (NDC 36000-047-24), or 150 mL (NDC 36000-048-24) bags.
Verify the lot numbers on the packaging. For 50 mL bags, affected lots include A061178, A061183, A061236 (Exp 09/2018), A0A0937 (Exp 08/2019), and A0A1044 or A0A1048 (Exp 10/2019).
For 100 mL bags, check for lots: A0A0741, A0A0747, A0A0748 (Exp 6/2019); A0A0814, A0A0815, A0A0823 (Exp 7/2019); A0A0889, A0A0893 (Exp 8/2019); A0A0954, A0A0958, A0A0970 (Exp 09/2019); A0A1005, A0A1006, A0A1008, A0A1012, A0A1016, A0A1028, and A0A1036 (Exp 10/2019).
For 150 mL bags, check for lots: A061243 (Exp 09/2018); A0A0258 (Exp 2/2019); A0A0813 (Exp 07/2019); A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925 (Exp 08/2019); A0A0971, A0A0976 (Exp 09/2019); A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, and A0A1004 (Exp 10/2019).
Contact your healthcare provider or pharmacist immediately for guidance if you are using this medication or have been administered it recently.
Stop using any medication from the affected lots immediately and return unused bags to the place of purchase or pharmacy for a refund.
Contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, IL, for further instructions regarding the return of the product.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare facilities and consumers can return the product for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL (50 mL)

Model:

NDC 36000-046-24

Lot Numbers:

A061178 (Exp 09/2018)

A061183 (Exp 09/2018)

A061236 (Exp 09/2018)

A0A0937 (Exp 08/2019)

A0A1044 (Exp 10/2019)

A0A1048 (Exp 10/2019)

Date Ranges: 09/2018, 08/2019, 10/2019

Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL (100 mL)

Model:

NDC 36000-047-24

Lot Numbers:

A0A0741 (Exp 6/2019)

A0A0747 (Exp 6/2019)

A0A0748 (Exp 6/2019)

A0A0814 (Exp 7/2019)

A0A0815 (Exp 7/2019)

A0A0823 (Exp 7/2019)

A0A0889 (Exp 8/2019)

A0A0893 (Exp 8/2019)

A0A0954 (Exp 09/2019)

A0A0958 (Exp 09/2019)

A0A0970 (Exp 09/2019)

A0A1005 (Exp 10/2019)

A0A1006 (Exp 10/2019)

A0A1008 (Exp 10/2019)

A0A1012 (Exp 10/2019)

A0A1016 (Exp 10/2019)

A0A1028 (Exp 10/2019)

A0A1036 (Exp 10/2019)

Date Ranges: 06/2019, 07/2019, 08/2019, 09/2019, 10/2019

Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL (150 mL)

Model:

NDC 36000-048-24

Lot Numbers:

A061243 (Exp 09/2018)

A0A0258 (Exp 2/2019)

A0A0813 (Exp 07/2019)

A0A0899 (Exp 08/2019)

A0A0904 (Exp 08/2019)

A0A0907 (Exp 08/2019)

A0A0914 (Exp 08/2019)

A0A0916 (Exp 08/2019)

A0A0921 (Exp 08/2019)

A0A0925 (Exp 08/2019)

A0A0971 (Exp 09/2019)

A0A0976 (Exp 09/2019)

A0A0994 (Exp 10/2019)

A0A0996 (Exp 10/2019)

A0A0997 (Exp 10/2019)

A0A0999 (Exp 10/2019)

A0A1000 (Exp 10/2019)

A0A1001 (Exp 10/2019)

A0A1003 (Exp 10/2019)

A0A1004 (Exp 10/2019)

Date Ranges: 09/2018, 02/2019, 07/2019, 08/2019, 09/2019, 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80987

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Pharmacies; Healthcare Facilities

Manufactured In: United States, India

Units Affected: 523,896 bags

Distributed To: Nationwide

Agency Last Updated: October 23, 2019

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

Risk

What You Should Do

Check your medical records or existing supplies for Levofloxacin Injection in 5% Dextrose (5 mg/mL) in 50 mL (NDC 36000-046-24), 100 mL (NDC 36000-047-24), or 150 mL (NDC 36000-048-24) bags.

Verify the lot numbers on the packaging. For 50 mL bags, affected lots include A061178, A061183, A061236 (Exp 09/2018), A0A0937 (Exp 08/2019), and A0A1044 or A0A1048 (Exp 10/2019).

For 100 mL bags, check for lots: A0A0741, A0A0747, A0A0748 (Exp 6/2019); A0A0814, A0A0815, A0A0823 (Exp 7/2019); A0A0889, A0A0893 (Exp 8/2019); A0A0954, A0A0958, A0A0970 (Exp 09/2019); A0A1005, A0A1006, A0A1008, A0A1012, A0A1016, A0A1028, and A0A1036 (Exp 10/2019).

For 150 mL bags, check for lots: A061243 (Exp 09/2018); A0A0258 (Exp 2/2019); A0A0813 (Exp 07/2019); A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925 (Exp 08/2019); A0A0971, A0A0976 (Exp 09/2019); A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, and A0A1004 (Exp 10/2019).

Contact your healthcare provider or pharmacist immediately for guidance if you are using this medication or have been administered it recently.

Stop using any medication from the affected lots immediately and return unused bags to the place of purchase or pharmacy for a refund.

Contact Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, IL, for further instructions regarding the return of the product.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL (50 mL)

Model:

NDC 36000-046-24

Lot Numbers:

A061178 (Exp 09/2018)

A061183 (Exp 09/2018)

A061236 (Exp 09/2018)

A0A0937 (Exp 08/2019)

A0A1044 (Exp 10/2019)

A0A1048 (Exp 10/2019)

Date Ranges: 09/2018, 08/2019, 10/2019

Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL (100 mL)

Model:

NDC 36000-047-24

Lot Numbers:

A0A0741 (Exp 6/2019)

A0A0747 (Exp 6/2019)

A0A0748 (Exp 6/2019)

A0A0814 (Exp 7/2019)

A0A0815 (Exp 7/2019)

A0A0823 (Exp 7/2019)

A0A0889 (Exp 8/2019)

A0A0893 (Exp 8/2019)

A0A0954 (Exp 09/2019)

A0A0958 (Exp 09/2019)

A0A0970 (Exp 09/2019)

A0A1005 (Exp 10/2019)

A0A1006 (Exp 10/2019)

A0A1008 (Exp 10/2019)

A0A1012 (Exp 10/2019)

A0A1016 (Exp 10/2019)

A0A1028 (Exp 10/2019)

A0A1036 (Exp 10/2019)

Date Ranges: 06/2019, 07/2019, 08/2019, 09/2019, 10/2019

Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL (150 mL)

Model:

NDC 36000-048-24

Lot Numbers:

A061243 (Exp 09/2018)

A0A0258 (Exp 2/2019)

A0A0813 (Exp 07/2019)

A0A0899 (Exp 08/2019)

A0A0904 (Exp 08/2019)

A0A0907 (Exp 08/2019)

A0A0914 (Exp 08/2019)

A0A0916 (Exp 08/2019)

A0A0921 (Exp 08/2019)

A0A0925 (Exp 08/2019)

A0A0971 (Exp 09/2019)

A0A0976 (Exp 09/2019)

A0A0994 (Exp 10/2019)

A0A0996 (Exp 10/2019)

A0A0997 (Exp 10/2019)

A0A0999 (Exp 10/2019)

A0A1000 (Exp 10/2019)

A0A1001 (Exp 10/2019)

A0A1003 (Exp 10/2019)

A0A1004 (Exp 10/2019)

Date Ranges: 09/2018, 02/2019, 07/2019, 08/2019, 09/2019, 10/2019