Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
Hospira Inc. is recalling Fentanyl Citrate Injection vials because improperly crimped flip-top seals may compromise 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Hospira Inc. is recalling 62,650 vials of Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial. The recall is due to a lack of assurance of sterility caused by improperly crimped flip-top vials.
The affected product is identified by Lot 41-099-DK, expiration date 01MAY2016, and NDC 0409-9094-61. The product was distributed nationwide. Fentanyl Citrate is a prescription-only medication (C-II) intended for intramuscular or intravenous use.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or replacement. Consumers should not use the product if they have any concerns about the integrity of the vial seal.
The recalled product
- Product
- FENTANYL CITRATE (FENTANYL CITRATE)
- Brand
- FENTANYL CITRATE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 62,650
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 (3)
- Lot 41-099-DK
- exp 01MAY2016
- NDC 0409-9094-61
Distribution
Distributed nationwide across the United States.
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