The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-309-2013·Announced 2013-05-08

Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns

Hospira Inc. is recalling 172,350 vials of Diazepam Injection due to a loose crimp on the fliptop vial 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failure in an injectable drug) are categorized as Severe (Score 4), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Hospira Inc. is recalling 172,350 vials of Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial. The recall affects Lot 17-100-EV and 17-399-EV, which were distributed nationwide and in Puerto Rico. The product is identified by NDC 0409-3213-12.

The recall was initiated because of a lack of assurance of sterility. Specifically, a loose crimp was applied to the fliptop vial, which may compromise the sterile integrity of the medication. This is a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should discontinue use of the affected lots and return them to the distributor or manufacturer. Consumers should check their medication vials for the specific lot numbers listed above and contact their pharmacist or physician for guidance on replacement or alternative treatment.

The recalled product

Product
DIAZEPAM (DIAZEPAM)
Brand
DIAZEPAM
Manufacturer
Hospira Inc.
Category
Drug — Injectable
Hazard
Affected units
172,350

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 17-100-EV and 17-399-EV

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 2 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 2 products in this recall →

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Same brand · DIAZEPAM

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Same hazard · sterility failure

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