Drug Safety Alerts

Ceftazidime for Injection and Dextrose for Injection Class I Recall

5/05/2020

On May 5, 2020, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of Ceftazidime for Injection USP and Dextrose for Injection NDC 00264-3145-11 manufactured by B Braun. This recall was issued due to failure in in stability testing. Out-of-specification (OOS) results for High Molecular Weight Polymers were found at the 82 week stability interval.

This could pose a health hazard or safety risk to patients using product affected by this recall.

This recall, which was issued to the hospital/user level, affects lot number H8J812, Exp. 07/31/2020.

Elevated levels of High Molecular Weight Polymers (HMWP) have been shown to cause kidney damage and liver issues in animal studies. B. Braun has advised that, while the impact of HMWP in humans is unknown, it is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels. B. Braun has further advised that to date there have been no complaints or reports of adverse reactions associated with this product lot.

Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: 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.

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. Ceftazidime for Injection USP and Dextrose Injection USP is packaged in 24 DUPLEX® Containers per case.

Please note: This recall was issued to the hospital/retail-level on April 22, 2020. The FDA classified this as a Class I recall on May 5, 2020.

CVS Caremark Response:

This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information regarding this recall, please call the B Braun Medical Affairs Department at 1‑800-227-2862, Monday through Friday, 8:00 AM to 6:00 PM (ET). You may also call the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.accessdata.fda.gov.