B. Braun Medical Inc. Recalls Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container

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The company is recalling the product because of out-of-specification results for high molecular weight polymers.

Braun Medical Inc. (B. Braun) is voluntarily recalling one lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 mL) in a Duplex Container. The recall is being conducted because of test results that exceeded specification limits for high molecular weight polymers (HMWP) in a 19-month stability interval.

According to the company, elevated HMWP levels have resulted in kidney damage and liver problems in animal studies, but the impact on humans is unknown. The company is recalling product out of caution. No adverse events have been reported as of the date of the recall. Adverse events may be reported to FDA through the agency’s MedWatch program.

Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial used to treat 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. According to the press release, “Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX Container is a flexible dual-chamber container containing approximately 50 mL of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime.”


Source: FDA