FDA Recall D-1257-2020
B. Braun Medical Inc · Irvine, CA
Class I — life-threatening Terminated 551 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1257-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed nationwide within the United States.
- Recall initiated
- 2020-04-18
- Classified by FDA Center
- 2020-04-28
- FDA published
- 2020-05-06
- Terminated
- 2021-10-21
- Recalling firm
- B. Braun Medical Inc
- Firm location
- Irvine, CA