Agency classClass IIOur severity:Severe FDA (Drugs)·D-0417-2015·Announced 2015-03-25

Hospira Recalls 5% Dextrose Injection Due to Sterility Concerns

Hospira is recalling 94,440 bags of 5% Dextrose Injection due to a potential leak at the administrative port that compromises 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as loss of sterility in an intravenous product.

Plain-English summary

Hospira, Inc. is recalling 94,440 bags of 5% Dextrose Injection, USP, 250 mL ADD-Vantage Unit. The affected product is identified by Lot 37-042-JT with an expiration date of January 2016. The recall is being conducted because there is a potential for the solution to leak at the administrative port of the primary container.

This leak creates a lack of assurance of sterility for the intravenous solution. The product was distributed nationwide. 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.

Healthcare providers and facilities should stop using the affected lots and contact Hospira for further instructions. Consumers should not use this prescription product and should consult their healthcare provider if they have questions regarding the recall.

The recalled product

Product: DEXTROSE (DEXTROSE MONOHYDRATE)
Brand: DEXTROSE
Manufacturer: Hospira Inc.
Category: Drug — Intravenous Solution
Hazard: sterility
leak
Affected units: 94,440

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: 37-042-JT
Exp 1JAN2016

UPCs (1)

003040409710

Distribution

Distributed nationwide across the United States.

Same brand · DEXTROSE

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Same manufacturer · Hospira Inc.

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Same hazard · sterility