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Class II: temporary or reversible health riskTerminated

Hospira Furosemide Injection Recall

Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIR…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
May 15, 2013
Recall ID
D-314-2013
Check your lot numberHow we source this data

Summary

Hospira recalled Furosemide Injection starting Feb 26, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-314-2013 on May 15, 2013. Reason: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Product description

Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04

Lot numbers, UPCs & expiration codes

Lot 20-564-DK Exp. 02/14

Where it was sold

Nationwide and Puerto Rico

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-314-2013
Classification
Class II
Status
Terminated
Recall initiated
Feb 26, 2013
FDA report date
May 15, 2013
Quantity
259,050 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-314-2013, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
65077
Address
275 N Field Dr
Code information
Lot 20-564-DK Exp. 02/14
Postal code
60045-2579
Report date
May 15, 2013
Product type
Drugs
Recall number
D-314-2013
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
259,050 vials
Termination date
Nov 10, 2014
Reason for recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Feb 26, 2013
Initial firm notification
Letter
Center classification date
May 6, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-314-2013, published May 15, 2013. 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.

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