FDAClass IIJune 26, 2013

0.9% Sodium Chloride Injection recall: Sterility Concern

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC…

Why was 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.

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 #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02

Product
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC…
Recalling firm
Hospira Inc.
Quantity
676,872 containers
Distribution
Nationwide and Puerto Rico
Recall date
June 26, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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