Drug product
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11
D-1268-2014
Product summary
- Event
- Event 66913
- Status
- Terminated
- Classification
- Class I
- Quantity
- 136,392 units
- Official record key
drug-enforcement:D-1268-2014
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# H2S725, H2S726, Exp 07/14; H3D724, Exp 11/14; H3E724, Exp 12/14; Lot# H3H507, Exp 01/15
Distribution pattern: Nationwide, Puerto Rico and Spain
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter