Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog ...
FDA Recall #D-1269-2014 — Class I — November 21, 2013
Product Description
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11
Reason for Recall
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recalling Firm
B. Braun Medical Inc — Irvine, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
42,576 units
Distribution
Nationwide, Puerto Rico and Spain
Code Information
Lot# H2S723, Exp 07/14; H3H711, Exp 01/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated