FDA recall D-1257-2020

Product

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.

Distribution

Product was distributed nationwide within the United States.

Key facts

Status

Terminated

Initiation date

2020-04-18

Report date

2020-05-06

Termination date

2021-10-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1257-2020