B. Braun Medical Inc recalls Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc…

Recall date

April 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1257-2020

FDA classification

Class I

Brand / firm

B. Braun Medical Inc

Sold / distributed

Product was distributed nationwide within the United States.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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