Brand name: B. Braun
Product recalled: Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container
Reason of the recall: Out-of-Specification Results for High Molecular Weight Polymers
FDA Recall date: April 20, 2020
Recall details: Braun Medical
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. The affected recalled product includes the following lot number and expiration date:
- NDC: 0264-3145-11. Ref: 3145-11. Dose/Volume: 2 g per 50 mL. Impacted batch: H8J812. Exp. Date: 31 Jul 2020.
Product was distributed Nationwide within the United States to domestic distributors. Pictures of the product and product labeling follow this press release.
B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department
Check the full recall details on www.fda.gov
Source: FDA