The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-927-2013·Announced 2013-09-04

Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns

Hospira Inc. is recalling 72,300 vials of Diazepam Injection due to ineffective crimps that may compromise 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential sterility issues in injectable medications.

Plain-English summary

Hospira Inc. is recalling 72,300 vials of Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial. The product is identified by NDC 0409-3213-12, Lot 23-505-EV, with an expiration date of 11/14.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that ineffective crimps on the fliptop vials may result in leaking at the neck of the vials, which poses a risk to the sterility of the medication.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled vials and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

Product
DIAZEPAM (DIAZEPAM)
Brand
DIAZEPAM
Manufacturer
Hospira Inc.
Category
Drug — Injectable
Hazard
Affected units
72,300

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: 23-505-EV
  • Exp. 11/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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