Medications & Supplements/Prescription Drugs

B. Braun Medical Inc: Ceftazidime and Dextrose Injection Recalled for Quality Specification Failure

Agency Publication Date: April 28, 2020

Summary

Approximately 22,488 units of Ceftazidime for Injection USP and Dextrose for Injection USP (2 g, 50 mL) are being recalled due to the presence of high molecular weight polymers. These polymers are impurities that exceeded allowed stability specifications, which means the drug may not be as safe or effective as intended. If you are a patient who has been treated with this medication, you should contact your healthcare provider or pharmacist for further guidance.

Risk

The presence of high molecular weight polymers above the allowed limit can affect the drug's safety profile and how well it works. Injecting medications with these types of impurities can lead to adverse medical reactions or a failure to properly treat the underlying infection.

What You Should Do

Identify the affected product by checking for Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Containers with NDC 0264-3145-11.
Check the packaging for Lot Number H8J812 and an expiration date of July 31, 2020 (31 JUL 2020).
Contact your healthcare provider or pharmacist immediately if you have this product or have recently been treated with it to discuss alternative treatments or any health concerns.
Return any unused product from the affected lot to the pharmacy or place of purchase for a refund.
Contact B. Braun Medical Inc. for further instructions or to ask specific questions about this recall.
For additional assistance or questions, call 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 consultation and product return for refund.

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

Affected Products

Product: Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container

Model:

NDC 0264-3145-11

Recall #: D-1257-2020

Lot Numbers:

H8J812 (Exp. Date 31 JUL 2020)

Date Ranges: Expiration Date: 31 JUL 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85507

Status: Resolved

Manufacturer: B. Braun Medical Inc

Sold By: Hospitals; Healthcare facilities; Pharmacies

Manufactured In: United States

Units Affected: 22,488 Duplex containers

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

Identify the affected product by checking for Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Containers with NDC 0264-3145-11.

Check the packaging for Lot Number H8J812 and an expiration date of July 31, 2020 (31 JUL 2020).

Contact your healthcare provider or pharmacist immediately if you have this product or have recently been treated with it to discuss alternative treatments or any health concerns.

Return any unused product from the affected lot to the pharmacy or place of purchase for a refund.

Contact B. Braun Medical Inc. for further instructions or to ask specific questions about this recall.

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