FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Hospira Fentanyl Citrate Injection Recall

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Nov 30, 2016
Recall ID
D-0153-2017
Check your lot numberHow we source this data

Summary

Hospira recalled Fentanyl Citrate Injection starting Nov 1, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0153-2017 on Nov 30, 2016. Reason: Lack of Assurance of Sterility: Complaints of broken tips on the ampules. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

Product description

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Lot numbers, UPCs & expiration codes

Lot #5 9277EV, 60028EV, 6008EV, Exp 11/1/17

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-0153-2017
Classification
Class II
Status
Terminated
Recall initiated
Nov 1, 2016
FDA report date
Nov 30, 2016
Quantity
797,800 ampules
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0153-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
75619
Address
600 N Field Dr
Code information
Lot #5 9277EV, 60028EV, 6008EV, Exp 11/1/17
Postal code
60045-4835
Report date
Nov 30, 2016
Product type
Drugs
Recall number
D-0153-2017
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
797,800 ampules
Termination date
Aug 28, 2018
Reason for recall
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
Distribution pattern
Nationwide
Recall initiation date
Nov 1, 2016
Initial firm notification
Letter
Center classification date
Nov 23, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0153-2017, published Nov 30, 2016. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls