FDAClass IIJuly 31, 2013

Sodium Chloride Injection recall: Particulate Matter

Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.

Why was Sodium Chloride Injection recalled?

Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.

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 #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01

Product
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
Recalling firm
Hospira Inc.
Quantity
268,700 vials
Distribution
Nationwide and Guam
Recall date
July 31, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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