FDAClass IIMarch 6, 2013

0.9% Sodium Chloride Irrigation recall: Sterility Concern

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

Why was 0.9% Sodium Chloride Irrigation recalled?

Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration 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 13-121-JT* * the lot number may be followed by 01

Product
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Recalling firm
Hospira Inc.
Quantity
56,854 Units
Distribution
Nationwide
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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