Drug 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
D-1054-2014
Product summary
- Event
- Event 66497
- Status
- Terminated
- Classification
- Class I
- Quantity
- 18,936 Containers
- Official record key
drug-enforcement:D-1054-2014
Official wording
Reason: 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.
Code information: Lot H3A744, Exp 01/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter