The Recall Desk
SevereFDA (Drugs)·D-615-2013·Announced 2013-07-03

Hospira Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Sterility Concerns

Hospira Inc. is voluntarily recalling 74,256 units of 5% Dextrose and 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While no specific injuries are reported in the text, the potential loss of sterility in an IV product is a significant health risk that aligns with the upper end of Class II severity.

Plain-English summary

Hospira Inc. is voluntarily recalling 74,256 units of 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container. The affected product is identified by Lot # 11-161-JT with an expiration date of 11/13. The recall is being conducted due to possible leaking bags, which raises concerns regarding the assurance of sterility.

The affected units were distributed nationwide, as well as in Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia. The source text does not report any specific illnesses or injuries associated with this recall.

Healthcare providers and consumers should stop using the affected product and contact Hospira Inc. for further instructions or replacement. This recall is classified as FDA Class II.

The recalled product

Product
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
Manufacturer
Hospira Inc.
Category
Drug — IV Fluids
Hazard
Affected units
74,256

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 (2)

  • Lot #: 11-161-JT
  • Exp 11/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · sterility compromise

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