FDA recall D-0094-2017
B. Braun Medical Inc · Class I · drug
Product
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
Reason for recall
Non-Sterility: fungal contamination due to leaking containers.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-03-25
- Report date
- 2016-10-19
- Termination date
- 2016-10-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Irvine, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2017