The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-612-2013·Announced 2013-07-03

Hospira Recalls 70% Dextrose Injection Due to Possible Leaking Bags

Hospira is voluntarily recalling 14,706 units of 70% Dextrose Injection USP due to possible leaking bags that may compromise sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, FDA Class II recalls involving significant injury/property-damage reports or structural defects (like leaking bags compromising sterility) fall under the Severe category, and the rule states that if the agency's classification is FDA Class I or II, the score should not be lower than 4 if significant risks are implied, though strictly Class II is often 3 or 4. Given the 'Lack of Assurance of Sterility' for an injectable drug, this represents a significant risk of harm, aligning with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Hospira, Inc. is voluntarily recalling 14,706 units of 70% Dextrose Injection USP, 2000 mL, Rx Only (NDC 0409-7120-07). The recall is being conducted due to possible leaking bags, which raises concerns about the assurance of sterility for the product.

The affected product is identified by Lot # 13-041-JT with an expiration date of 1/14. The distribution pattern for these units includes nationwide distribution, Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia.

Consumers and healthcare providers should stop using the affected product and contact Hospira, Inc. for further instructions or a replacement. This recall is classified as Class II by the FDA.

The recalled product

Product
70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
Manufacturer
Hospira Inc.
Category
Drug — Injectable
Hazard
Affected units
14,706

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 #: 13-041-JT
  • Exp 1/14

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 →

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