The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-614-2013·Announced 2013-07-03

Hospira Recalls 5% Dextrose Injection Due to Sterility Concerns

Hospira is voluntarily recalling 5% Dextrose Injection USP bags due to possible leaking that compromises sterility assurance.

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, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

Hospira, Inc. is voluntarily recalling 5% Dextrose Injection USP in 250 mL and 500 mL sizes. The recall is initiated due to possible leaking bags, which raises concerns about the assurance of sterility for the product.

The affected lots are 01-201-JT (expiring 7/12) and 91-054-JT (expiring 7/12). The recall covers 267,288 units distributed nationwide, as well as in Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia.

Healthcare providers and patients should check their inventory for these specific lot numbers and stop using the affected products. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
Manufacturer
Hospira Inc.
Category
Drug — Injectable Solution
Hazard
Affected units
267,288

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 #: a) 01-201-JT
  • Exp 7/12
  • b) Lot 91-054-JT

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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