The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-313-2013·Announced 2013-05-15

Hospira Recalls Diazepam Injection Due to Sterility Assurance Concerns

Hospira Inc. is recalling 114,000 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of whether specific injuries are reported in the text.

Plain-English summary

Hospira Inc. is recalling 114,000 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 05-585-EV with an expiration date of 05/13. The product was distributed nationwide and in Puerto Rico. The FDA has classified this recall as Class II.

Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or a replacement.

The recalled product

Product
DIAZEPAM (DIAZEPAM)
Brand
DIAZEPAM
Manufacturer
Hospira Inc.
Category
Drug — Injection
Hazard
Affected units
114,000

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 05-585-EV Exp. 05/13

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 4 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 4 products in this recall →

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