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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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.
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