April 21, 2020

Braun Medical has voluntarily recalled one lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50mL) in Duplex® Containers. The recall was issued after testing determined the products exceed limits on High Molecular Weight Polymers (HMWP).

Elevated HMWP levels have been shown to cause kidney and liver problems in animal studies, but their effect on humans is currently unknown. Braun Medical has issued its voluntary recall out of an abundance of caution to prevent the risk of adverse reactions due to elevated HMWP in the affected products. As of the date of the recall, no adverse events had been reported.

Ceftazidime for Injection USP and Dextrose Injection USP is an antibacterial treatment indicated for infections caused by susceptible microorganisms. These infections include lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections, and central nervous system infections. The recalled product is packaged in DUPLEX containers that contain both the dextrose and the ceftazidime. The dextrose solution and ceftazidime are mixed together to create a solution equivalent to 2g of ceftazidime that is administered in a clinical setting.

Facilities and distributors in possession of the recalled product should discontinue use immediately and contact Braun Medical Customer Support at 1-800-227-2862 to arrange a product return or to address any questions they may have. Patients who may have been treated with the recalled product should contact their healthcare provider if they have experienced any problems that may be related to its use. Adverse events can also be reported to the U.S. FDA’s MedWatch program.

Additional information regarding the recall is available on the FDA’s website.

There is no member impact through Benecard Central Fill.

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