FDA Recall D-1054-2014
B. Braun Medical Inc · Irvine, CA
Class I — life-threatening Terminated 415 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
Reason for recall
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Recall record
- Recall number
D-1054-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2013-10-15
- Classified by FDA Center
- 2014-01-31
- FDA published
- 2014-02-12
- Terminated
- 2014-12-04
- Recalling firm
- B. Braun Medical Inc
- Firm location
- Irvine, CA
Drug identification
- Brand name(s)
- CEFEPIME HYDROCHLORIDE AND DEXTROSE
- Generic name(s)
- CEFEPIME HYDROCHLORIDE
- Manufacturer(s)
- B. Braun Medical Inc.
- NDC(s)
0264-3193, 0264-3195- Route(s)
- INTRAVENOUS