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Class II: temporary or reversible health riskTerminated

Hospira Fentanyl Citrate Injection Recall

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vi…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Dec 17, 2014
Recall ID
D-0294-2015
Check your lot numberHow we source this data

Summary

Hospira recalled Fentanyl Citrate Injection starting Dec 3, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0294-2015 on Dec 17, 2014. Reason: Lack of Assurance of Sterility; improperly crimped fliptop vials. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; improperly crimped fliptop vials

Product description

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 Inc., Lake Forest, IL --- NDC 0409-9094-61

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0294-2015
Classification
Class II
Status
Terminated
Recall initiated
Dec 3, 2014
FDA report date
Dec 17, 2014
Quantity
62,650 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0294-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
69971
Address
375 N Field Dr
Code information
Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61
Postal code
60045-2513
Report date
Dec 17, 2014
Product type
Drugs
Recall number
D-0294-2015
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
62,650 vials
Termination date
Oct 2, 2015
Reason for recall
Lack of Assurance of Sterility; improperly crimped fliptop vials
Voluntary / mandated
Voluntary: Firm initiated
Product description
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 Inc., Lake Forest, IL --- NDC 0409-9094-61
Distribution pattern
Nationwide
Recall initiation date
Dec 3, 2014
Initial firm notification
Letter
Center classification date
Dec 10, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0294-2015, published Dec 17, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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