Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-...
FDA Recall #D-1264-2014 — Class I — November 21, 2013
Product Description
Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11
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
22,584 units
Distribution
Nationwide, Puerto Rico and Spain
Code Information
Lot# H3E507, Exp 11/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated