PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 7, 2014 Initiated: November 21, 2013 #D-1264-2014

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.

Details

Recalling Firm
B. Braun Medical Inc
Units Affected
22,584 units
Distribution
Nationwide, Puerto Rico and Spain
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by B. Braun Medical Inc. Units affected: 22,584 units.
Why was this product recalled?
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 7, 2014. Severity: Critical. Recall number: D-1264-2014.