FDA Recall D-1267-2014
B. Braun Medical Inc · Irvine, CA
Class I — life-threatening Terminated 378 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11
Reason for recall
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall record
- Recall number
D-1267-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide, Puerto Rico and Spain
- Recall initiated
- 2013-11-21
- Classified by FDA Center
- 2014-04-25
- FDA published
- 2014-05-07
- 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