The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-501-2013·Announced 2013-06-12

Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns

Hospira Inc. is recalling 95,700 vials of Diazepam Injection due to a loose crimp on the fliptop vial, which 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the defect is structural/sterility-related.

Plain-English summary

Hospira Inc. is recalling 95,700 vials of Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial. The recall is due to a lack of assurance of sterility caused by a loose crimp applied to the fliptop vial. The affected product is identified by lot number 17-099-EV and has an expiration date of 05/14.

The recalled product was distributed nationwide and in Puerto Rico. 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, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. or their local FDA office for further instructions on returning the product.

The recalled product

Product
DIAZEPAM (DIAZEPAM)
Brand
DIAZEPAM
Manufacturer
Hospira Inc.
Category
Drug — Injectable
Hazard
Affected units
95,700

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)

  • 17-099-EV Exp 05/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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