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.
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 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
- 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
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 →Related recalls
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