Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number...

FDA Recall #D-1266-2014 — Class I — November 21, 2013

Recall #D-1266-2014 Date: November 21, 2013 Classification: Class I Status: Terminated

Product Description

Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895

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

32,376 units

Distribution

Nationwide, Puerto Rico and Spain

Code Information

Lot# H3B702, Exp 02/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated