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Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog N...

FDA Recall #D-1267-2014 — Class I — November 21, 2013

Recall #D-1267-2014 Date: November 21, 2013 Classification: Class I Status: Terminated

Product Description

Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11

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

22,248 units

Distribution

Nationwide, Puerto Rico and Spain

Code Information

Lot# H2L712, Exp 09/14

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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