The Recall Desk
SevereFDA (Drugs)·D-0279-2015·Announced 2014-12-03

Hospira Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

Hospira is recalling 301,560 bags of 5% Dextrose Injection 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. According to the rubric, an FDA Class II recall involving a risk of harm (loss of sterility in an IV product) without reported fatalities or hospitalizations is categorized as Severe.

Plain-English summary

Hospira, Inc. is recalling 301,560 bags of 5% Dextrose Injection, USP, 1000 mL container. The recall involves specific lots: Lot # 33-094-JT (Exp. 09/15) and Lot # 35-028-JT (Exp. 11/15). 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 sterile integrity of the injection.

Healthcare providers and patients should stop using the affected product. Consumers should check their inventory for the specific NDC 0409-7922-09 and the lot numbers listed above. If the product is found, it should be returned to the pharmacy or supplier for disposal or replacement.

The recalled product

Product
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
Manufacturer
Hospira Inc.
Category
Drug — IV Solution
Hazard
Affected units
301,560

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 # 33-094-JT
  • Exp. 09/15 Lot # 35-028-JT
  • Exp. 11/15

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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