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Class I: serious health riskTerminated

Hospira Lactated Ringer's and 5% Dextrose Injection Recall

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only,…

Hospira Inc. · Lake Forest, IL

Risk level
Class I
Reported by FDA
Apr 24, 2013
Recall ID
D-263-2013
Check your lot numberHow we source this data

Summary

Hospira recalled Lactated Ringer's and 5% Dextrose Injection starting Oct 5, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-263-2013 on Apr 24, 2013. Reason: Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold. Status: Terminated.

Why it was recalled

Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.

Product description

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.

Lot numbers, UPCs & expiration codes

Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90

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-263-2013
Classification
Class I
Status
Terminated
Recall initiated
Oct 5, 2012
FDA report date
Apr 24, 2013
Quantity
136,224 flexible containers
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-263-2013, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
63432
Address
275 N Field Dr
Code information
Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90
Postal code
60045-2579
Report date
Apr 24, 2013
Product type
Drugs
Recall number
D-263-2013
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
136,224 flexible containers
Termination date
Aug 21, 2015
Reason for recall
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
Distribution pattern
Nationwide
Recall initiation date
Oct 5, 2012
Initial firm notification
Press Release
Center classification date
Apr 17, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-263-2013, published Apr 24, 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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