PlainRecalls
FDA Drug Critical Class I Terminated

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

Reported: May 6, 2020 Initiated: April 18, 2020 #D-1257-2020

Product Description

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

Reason for Recall

Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.

Details

Recalling Firm
B. Braun Medical Inc
Units Affected
22,488 Duplex containers
Distribution
Product was distributed nationwide within the United States.
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11. Recalled by B. Braun Medical Inc. Units affected: 22,488 Duplex containers.
Why was this product recalled?
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 6, 2020. Severity: Critical. Recall number: D-1257-2020.