The Recall Desk
SevereFDA (Drugs)·D-183-2013·Announced 2013-03-13

Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

Hospira Inc. is recalling 325,056 bags of 0.9% Sodium Chloride Injection USP, 100 mL, due to a potential lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk defects.

Plain-English summary

Hospira Inc. is recalling 325,056 bags of 0.9% Sodium Chloride Injection USP, 100 mL (NDC 0409-7984-23). The affected product is identified by Lot Number 02-117-JT with an expiration date of 02/13. The recall is being conducted nationwide.

The recall is due to a lack of assurance of sterility. There is a potential for the solution to leak from the administrative port to the fill tube seal. This defect could compromise the sterility of the injection.

Healthcare providers and facilities should stop using the affected product and contact Hospira Inc. for further instructions. Consumers should not use this product if they have it in their possession.

The recalled product

Product
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
Manufacturer
Hospira Inc.
Category
Drug — Injection
Hazard
Affected units
325,056

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number 02-117-JT Exp. 02/13

Distribution

Distributed nationwide across the United States.

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Same hazard · sterility

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