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Class II: temporary or reversible health riskTerminated

Hospira 0.9% Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc.,…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Mar 12, 2014
Recall ID
D-1096-2014
Check your lot numberHow we source this data

Summary

Hospira recalled 0.9% Sodium Chloride Injection starting Feb 11, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1096-2014 on Mar 12, 2014. Reason: Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.

Product description

0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09

Lot numbers, UPCs & expiration codes

Lot 34-609-FW; Exp 10/15

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-1096-2014
Classification
Class II
Status
Terminated
Recall initiated
Feb 11, 2014
FDA report date
Mar 12, 2014
Quantity
603,768 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-1096-2014, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
67605
Address
275 N Field Dr
Code information
Lot 34-609-FW; Exp 10/15
Postal code
60045-2579
Report date
Mar 12, 2014
Product type
Drugs
Recall number
D-1096-2014
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
603,768 bags
Termination date
Mar 17, 2015
Reason for recall
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Feb 11, 2014
Initial firm notification
Letter
Center classification date
Mar 3, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1096-2014, published Mar 12, 2014. 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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