The Recall Desk
SevereFDA (Drugs)·D-0277-2015·Announced 2014-12-03

Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns

Hospira is recalling 152,172 bags of Normosol-R IV solution due to potential punctures that may compromise sterility and cause leaks.

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 with potential for significant injury or property damage (such as sterility failure in IV products) are rated as Severe (4).

Plain-English summary

Hospira Inc. is recalling 152,172 bags of Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL containers. The recall affects Lot # 32-082-JT with an expiration date of 08/15. The product was distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands.

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 sterility of the intravenous solution.

Consumers and healthcare providers should stop using the affected product immediately. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
Manufacturer
Hospira Inc.
Category
Drug — IV Solution
Hazard
Affected units
152,172

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 # 32-082-JT
  • Exp. 08/15

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 →

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