PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 12, 2014 Initiated: October 15, 2013 #D-1054-2014

Product Description

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.

Details

Recalling Firm
B. Braun Medical Inc
Units Affected
18,936 Containers
Distribution
Nationwide
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by B. Braun Medical Inc. Units affected: 18,936 Containers.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 12, 2014. Severity: Critical. Recall number: D-1054-2014.