The Recall Desk
SevereFDA (Drugs)·D-0280-2015·Announced 2014-12-03

Hospira Recalls IV Bags Due to Potential Sterility Breach

Hospira is recalling 823,296 bags of 5% Dextrose and 0.45% Sodium Chloride Injection due to potential punctures 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, an FDA Class II recall involving a risk of serious injury (loss of sterility in an IV product) corresponds to a severity score of 4.

Plain-English summary

Hospira Inc. is recalling 823,296 bags of 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container. The affected product is identified by NDC 0409-7926-09 and includes Lot # 33-095-JT (Exp. 09/15) and Lot # 36-030-JT (Exp. 12/15).

The recall was initiated due to a lack of assurance of sterility. The source text indicates a potential for punctures through the overwrap and primary container, which may result in IV bag leaks. This defect could compromise the sterile integrity of the intravenous solution.

The product was distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands. Healthcare providers and patients should stop using the affected lots and contact their supplier or Hospira for further instructions.

The recalled product

Product
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
Manufacturer
Hospira Inc.
Category
Drug — Intravenous Solution
Hazard
Affected units
823,296

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 (3)

  • Lot # 33-095-JT
  • Exp. 09/15 Lot # 36-030-JT
  • Exp. 12/15

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 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 11 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · loss of sterility

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