Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Levofloxacin Injection Recalled for Excessive Potency and Concentration

Agency Publication Date: August 3, 2018

Summary

Baxter Healthcare Corporation is recalling over 1 million bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification results that cause the medication to be superpotent. These injectable antibiotic bags (available in 250 mg, 500 mg, and 750 mg strengths) contain an increased concentration of the drug beyond what is specified on the label. The affected products were manufactured for Claris Lifesciences and distributed nationwide throughout the United States and Puerto Rico.

Risk

Using a superpotent drug means a patient may receive a higher dose of the antibiotic than intended. An overdose of levofloxacin can lead to increased side effects or toxicity, potentially impacting patient safety and the effectiveness of the treatment plan.

What You Should Do

Check your medical supplies for Levofloxacin Injection in 5% Dextrose bags (250 mg/50 mL, 500 mg/100 mL, or 750 mg/150 mL) with NDC numbers 36000-046-24, 36000-047-24, or 36000-048-24.
For 250 mg bags, identify affected lot numbers: A061178, A061183, A061236 (Exp 09/18); A0A0937 (Exp 08/19); A0A1044, A0A1048 (Exp 10/19).
For 500 mg bags, identify affected lot numbers: A0A0954, A0A0958, A0A0970 (Exp 09/19).
For 750 mg bags, identify affected lot numbers: A060940, A060948, A060951, A060956, A060958, A060963 (Exp 07/18); A061105, A061110, A061113, A061115, A061119 (Exp 08/18); A061243 (Exp 09/18); A0A0813 (Exp 07/19); A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925 (Exp 08/19); A0A0971, A0A0976 (Exp 09/19); A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004 (Exp 10/19).
Contact your healthcare provider or pharmacist immediately for guidance and to arrange for a replacement if you have an affected product.
Return any unused recalled product to the pharmacy or place of purchase for a refund and contact Baxter Healthcare Corporation at 1-888-229-0001 for further instructions.
For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy return

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, 250 mg (5 mg/mL), 50 mL Single Use Container bag

Model:

NDC 36000-046-24

Lot Numbers:

A061178 (Exp 09/18)

A061183 (Exp 09/18)

A061236 (Exp 09/18)

A0A0937 (Exp 08/19)

A0A1044 (Exp 10/19)

A0A1048 (Exp 10/19)

Date Ranges: September 2018, August 2019, October 2019

Product: Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 100 mL Single Use Container bag

Model:

NDC 36000-047-24

Lot Numbers:

A0A0954 (Exp 09/19)

A0A0958 (Exp 09/19)

A0A0970 (Exp 09/19)

Date Ranges: September 2019

Product: Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 150 mL Single Use Container bag

Model:

NDC 36000-048-24

Lot Numbers:

A060940 (Exp 07/18)

A060948 (Exp 07/18)

A060951 (Exp 07/18)

A060956 (Exp 07/18)

A060958 (Exp 07/18)

A060963 (Exp 07/18)

A061105 (Exp 08/18)

A061110 (Exp 08/18)

A061113 (Exp 08/18)

A061115 (Exp 08/18)

A061119 (Exp 08/18)

A061243 (Exp 09/18)

A0A0813 (Exp 07/19)

A0A0899 (Exp 08/19)

A0A0904 (Exp 08/19)

A0A0907 (Exp 08/19)

A0A0914 (Exp 08/19)

A0A0916 (Exp 08/19)

A0A0921 (Exp 08/19)

A0A0925 (Exp 08/19)

A0A0971 (Exp 09/19)

A0A0976 (Exp 09/19)

A0A0994 (Exp 10/19)

A0A0996 (Exp 10/19)

A0A0997 (Exp 10/19)

A0A0999 (Exp 10/19)

A0A1000 (Exp 10/19)

A0A1001 (Exp 10/19)

A0A1003 (Exp 10/19)

A0A1004 (Exp 10/19)

Date Ranges: July 2018, August 2018, September 2018, July 2019, August 2019, September 2019, October 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80653

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Pharmacies

Manufactured In: United States, India

Units Affected: 3 products (191,256 bags; 106,320 bags; 711,216 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

Check your medical supplies for Levofloxacin Injection in 5% Dextrose bags (250 mg/50 mL, 500 mg/100 mL, or 750 mg/150 mL) with NDC numbers 36000-046-24, 36000-047-24, or 36000-048-24.

For 250 mg bags, identify affected lot numbers: A061178, A061183, A061236 (Exp 09/18); A0A0937 (Exp 08/19); A0A1044, A0A1048 (Exp 10/19).

For 500 mg bags, identify affected lot numbers: A0A0954, A0A0958, A0A0970 (Exp 09/19).

For 750 mg bags, identify affected lot numbers: A060940, A060948, A060951, A060956, A060958, A060963 (Exp 07/18); A061105, A061110, A061113, A061115, A061119 (Exp 08/18); A061243 (Exp 09/18); A0A0813 (Exp 07/19); A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925 (Exp 08/19); A0A0971, A0A0976 (Exp 09/19); A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004 (Exp 10/19).

Contact your healthcare provider or pharmacist immediately for guidance and to arrange for a replacement if you have an affected product.

Return any unused recalled product to the pharmacy or place of purchase for a refund and contact Baxter Healthcare Corporation at 1-888-229-0001 for further instructions.

For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 50 mL Single Use Container bag

Model:

NDC 36000-046-24

Lot Numbers:

A061178 (Exp 09/18)

A061183 (Exp 09/18)

A061236 (Exp 09/18)

A0A0937 (Exp 08/19)

A0A1044 (Exp 10/19)

A0A1048 (Exp 10/19)

Date Ranges: September 2018, August 2019, October 2019

Product: Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 100 mL Single Use Container bag

Model:

NDC 36000-047-24

Lot Numbers:

A0A0954 (Exp 09/19)

A0A0958 (Exp 09/19)

A0A0970 (Exp 09/19)

Date Ranges: September 2019

Product: Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 150 mL Single Use Container bag

Model:

NDC 36000-048-24

Lot Numbers:

A060940 (Exp 07/18)

A060948 (Exp 07/18)

A060951 (Exp 07/18)

A060956 (Exp 07/18)

A060958 (Exp 07/18)

A060963 (Exp 07/18)

A061105 (Exp 08/18)

A061110 (Exp 08/18)

A061113 (Exp 08/18)

A061115 (Exp 08/18)

A061119 (Exp 08/18)

A061243 (Exp 09/18)

A0A0813 (Exp 07/19)

A0A0899 (Exp 08/19)

A0A0904 (Exp 08/19)

A0A0907 (Exp 08/19)

A0A0914 (Exp 08/19)

A0A0916 (Exp 08/19)

A0A0921 (Exp 08/19)

A0A0925 (Exp 08/19)

A0A0971 (Exp 09/19)

A0A0976 (Exp 09/19)

A0A0994 (Exp 10/19)

A0A0996 (Exp 10/19)

A0A0997 (Exp 10/19)

A0A0999 (Exp 10/19)

A0A1000 (Exp 10/19)

A0A1001 (Exp 10/19)

A0A1003 (Exp 10/19)

A0A1004 (Exp 10/19)

Date Ranges: July 2018, August 2018, September 2018, July 2019, August 2019, September 2019, October 2019