Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
Hospira is recalling 47,400 vials of Fentanyl Citrate Injection because loose or missing vial crimps raise concerns about sterility.
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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or other adverse health consequences.
Plain-English summary
Hospira, Inc. is recalling 47,400 vials of Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL (50 mcg/mL), 50 mL Single-dose Fliptop Vial. The product is identified by NDC 0409-9094-61, Lot # 39474DK, and an expiry date of 03/01/2016. The recall was initiated due to a lack of assurance of sterility, specifically because the fliptop vial crimps are loose or missing.
The affected product was distributed nationwide in the United States. Fentanyl Citrate is a prescription-only medication administered via intramuscular or intravenous routes. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific lot number and expiry date listed above. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- FENTANYL CITRATE (FENTANYL CITRATE)
- Brand
- FENTANYL CITRATE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 47,400
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 #: 39474DK
- Expiry: 03/01/2016.
Distribution
Distributed nationwide across the United States.
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