FDA Recall D-0094-2017
B. Braun Medical Inc · Irvine, CA
Class I — life-threatening Terminated 201 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0094-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2016-03-25
- Classified by FDA Center
- 2016-10-12
- FDA published
- 2016-10-19
- Terminated
- 2016-10-12
- Recalling firm
- B. Braun Medical Inc
- Firm location
- Irvine, CA