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Class II: temporary or reversible health riskTerminated

ICU Medical 5% Dextrose Injection Recall

5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20

ICU Medical Inc · LAKE FOREST, IL

Risk level
Class II
Reported by FDA
Nov 14, 2018
Recall ID
D-0215-2019
Check your lot numberHow we source this data

Summary

ICU Medical recalled 5% Dextrose Injection starting Oct 8, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0215-2019 on Nov 14, 2018. Reason: Lack of Assurance of Sterility; bags have the potential to leak. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; bags have the potential to leak

Product description

5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045

Lot numbers, UPCs & expiration codes

Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019

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-0215-2019
Classification
Class II
Status
Terminated
Recall initiated
Oct 8, 2018
FDA report date
Nov 14, 2018
Quantity
372,912 bags
Recall type
Voluntary: Firm initiated
Recalling firm
ICU Medical Inc

Original FDA data

Every field from FDA enforcement report D-0215-2019, exactly as published.

Show all FDA fields
City
LAKE FOREST
State
IL
Status
Terminated
Country
United States
Event ID
81199
Address
600 N FIELD DRIVE
Code information
Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019
Postal code
60045
Report date
Nov 14, 2018
Product type
Drugs
Recall number
D-0215-2019
Classification
Class II
Recalling firm
ICU Medical Inc
Product quantity
372,912 bags
Termination date
Mar 8, 2021
Reason for recall
Lack of Assurance of Sterility; bags have the potential to leak
Voluntary / mandated
Voluntary: Firm initiated
Product description
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Distribution pattern
Nationwide.
Recall initiation date
Oct 8, 2018
Initial firm notification
Letter
Center classification date
Nov 2, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0215-2019, published Nov 14, 2018. 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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