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Class I: serious health riskTerminated

Hospira 0.9% Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc.…

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
Sep 4, 2013
Recall ID
D-922-2013
Check your lot numberHow we source this data

Summary

Hospira recalled 0.9% Sodium Chloride Injection starting Aug 31, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-922-2013 on Sep 4, 2013. Reason: Presence of Particulate Matter; product may contain fibrous material. Status: Terminated.

Why it was recalled

Presence of Particulate Matter; product may contain fibrous material

Product description

0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23

Lot numbers, UPCs & expiration codes

Lot Number 05-201-JT, Expiration Date 1MAY2013

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-922-2013
Classification
Class I
Status
Terminated
Recall initiated
Aug 31, 2012
FDA report date
Sep 4, 2013
Quantity
264,432 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-922-2013, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
63364
Address
275 N Field Dr
Code information
Lot Number 05-201-JT, Expiration Date 1MAY2013
Postal code
60045-2579
Report date
Sep 4, 2013
Product type
Drugs
Recall number
D-922-2013
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
264,432 bags
Termination date
May 28, 2015
Reason for recall
Presence of Particulate Matter; product may contain fibrous material
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
Distribution pattern
Nationwide
Recall initiation date
Aug 31, 2012
Initial firm notification
Letter
Center classification date
Aug 26, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-922-2013, published Sep 4, 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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