Agency classClass IIOur severity:Severe FDA (Drugs)·D-502-2013·Announced 2013-06-12

Hospira Recalls Dobutamine in Dextrose Injection Due to Sterility Concerns

Hospira Inc. is recalling 44,748 bags of Dobutamine in Dextrose Injection because a confirmed leak in the primary container raises concerns about 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (leaking container compromising sterility) align with a score of 4 (Severe), as the agency's own classification mandates a score of at least 4 for Class I/II drug recalls involving significant risks.

Plain-English summary

Hospira Inc. is voluntarily recalling 44,748 bags of DOBUTAMINE in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag. The recall is being conducted due to a confirmed report of leaking in the primary container, which creates a lack of assurance of sterility for the affected product.

The affected product is identified by Lot 11-309-KL and NDC 0409-2346-32. The recall covers distribution nationwide and in Puerto Rico. This is a prescription-only intravenous medication manufactured by Hospira, Inc. in Lake Forest, Illinois.

Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the manufacturer for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: DOBUTAMINE IN DEXTROSE (DOBUTAMINE IN DEXTROSE)
Brand: DOBUTAMINE IN DEXTROSE
Manufacturer: Hospira Inc.
Category: Drug — Prescription Injection
Hazard: sterility
container-leak
Affected units: 44,748

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 (1)

Lot 11-309-KL

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Hospira Inc.

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Same hazard · sterility