FDAClass IIDecember 17, 2014

Fentanyl Citrate Injection recall: Sterility Concern

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira…

Why was Fentanyl Citrate Injection recalled?

Lack of Assurance of Sterility; improperly crimped fliptop vials

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61

Product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira…
Recalling firm
Hospira Inc.
Quantity
62,650 vials
Distribution
Nationwide
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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