Drug 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
D-1267-2014
Product summary
- Event
- Event 66913
- Status
- Terminated
- Classification
- Class I
- Quantity
- 22,248 units
- Official record key
drug-enforcement:D-1267-2014
Official wording
Reason: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Code information: Lot# H2L712, Exp 09/14
Distribution pattern: Nationwide, Puerto Rico and Spain
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter