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Class II: temporary or reversible health riskTerminated

Hospira Heparin Sodium 2000 Heparin Units per 1000 mL Recall

Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Feb 5, 2014
Recall ID
D-1036-2014
Check your lot numberHow we source this data

Summary

Hospira recalled Heparin Sodium 2000 Heparin Units per 1000 mL starting Jan 9, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1036-2014 on Feb 5, 2014. Reason: Lack of Assurance of Sterility; potential leakage from administrative port. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; potential leakage from administrative port.

Product description

Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.

Lot numbers, UPCs & expiration codes

Lot #: 26-125-JT, Exp: 8/14

Where it was sold

Nationwide including 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-1036-2014
Classification
Class II
Status
Terminated
Recall initiated
Jan 9, 2014
FDA report date
Feb 5, 2014
Quantity
27780 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-1036-2014, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
67317
Address
275 N Field Dr
Code information
Lot #: 26-125-JT, Exp: 8/14
Postal code
60045-2579
Report date
Feb 5, 2014
Product type
Drugs
Recall number
D-1036-2014
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
27780 bags
Termination date
May 19, 2015
Reason for recall
Lack of Assurance of Sterility; potential leakage from administrative port.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.
Distribution pattern
Nationwide including Puerto Rico
Recall initiation date
Jan 9, 2014
Initial firm notification
Letter
Center classification date
Jan 24, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1036-2014, published Feb 5, 2014. View the source record (openFDA) · FDA enforcement reports

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

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