Recalls / Class I
Class ID-1054-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Cefepime Hydrochloride And Dextrose
- Generic name
- Cefepime Hydrochloride
- Active ingredient
- Cefepime Hydrochloride
- Route
- Intravenous
- NDCs
- 0264-3193, 0264-3195
- FDA application
- NDA050821
- Affected lot / code info
- Lot H3A744, Exp 01/15
Why it was recalled
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.
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2525 McGaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 18,936 Containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-15
- FDA classified
- 2014-01-31
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1054-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.