Hospira Recalls Furosemide Injection Vials Due to Sterility Concerns
Hospira Inc. is recalling 259,050 vials of Furosemide Injection due to a loose crimp on the vial cap 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 identifies a 'Lack of Assurance of Sterility' for an injectable drug, which poses a significant risk of serious injury or death from infection, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Hospira Inc. is recalling 259,050 vials of Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial. The recall is being conducted because a loose crimp was applied to the fliptop vial, which results in a lack of assurance of sterility.
The affected product is identified by Lot 20-564-DK with an expiration date of 02/14. 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 their pharmacist or the manufacturer for further instructions. Consumers should not use the product if they have questions regarding its sterility.
The recalled product
- Product
- FUROSEMIDE (FUROSEMIDE)
- Brand
- FUROSEMIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Affected units
- 259,050
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 20-564-DK Exp. 02/14
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.
See all 4 products in this recall →Related recalls
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