FDAClass IOctober 19, 2016

5% Dextrose Injection USP recall: Sterility Concern

5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32

Why was 5% Dextrose Injection USP recalled?

Non-Sterility: fungal contamination due to leaking containers.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: J5J706, Exp. 10/31/2016

Product
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
Recalling firm
B. Braun Medical Inc
Quantity
57,408 units
Distribution
Nationwide
Recall date
October 19, 2016
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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