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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
Feb 25, 2015
Recall ID
D-0392-2015
Check your lot numberHow we source this data

Summary

Hospira recalled LACTATED RINGER'S and 5% DEXTROSE Injection starting Jul 10, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-0392-2015 on Feb 25, 2015. Reason: Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold. Status: Terminated.

Why it was recalled

Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.

Product description

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09

Lot numbers, UPCs & expiration codes

Lot # 35-118- JT, Exp. 11/15

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-0392-2015
Classification
Class I
Status
Terminated
Recall initiated
Jul 10, 2014
FDA report date
Feb 25, 2015
Quantity
142,644 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0392-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
68764
Address
275 N Field Dr
Code information
Lot # 35-118- JT, Exp. 11/15
Postal code
60045-2579
Report date
Feb 25, 2015
Product type
Drugs
Recall number
D-0392-2015
Classification
Class I
Recalling firm
Hospira Inc.
Product quantity
142,644 bags
Termination date
Nov 23, 2015
Reason for recall
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, 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 600045, NDC 0409-7929-09
Distribution pattern
Nationwide
Recall initiation date
Jul 10, 2014
Initial firm notification
Press Release
Center classification date
Feb 17, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0392-2015, published Feb 25, 2015. View the source record (openFDA) · FDA enforcement reports

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

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