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Class II: temporary or reversible health riskTerminated

Baxter Healthcare 10% Dextrose Injection Recall

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healt…

Baxter Healthcare Corp. · Round Lake, IL

Risk level
Class II
Reported by FDA
Oct 3, 2012
Recall ID
D-1687-2012
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 10% Dextrose Injection starting Sep 21, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1687-2012 on Oct 3, 2012. Reason: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). Status: Terminated.

Why it was recalled

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Product description

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03

Lot numbers, UPCs & expiration codes

Lot #: C832840, Exp 02/13

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-1687-2012
Classification
Class II
Status
Terminated
Recall initiated
Sep 21, 2012
FDA report date
Oct 3, 2012
Quantity
2,976 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-1687-2012, exactly as published.

Show all FDA fields
City
Round Lake
State
IL
Status
Terminated
Country
United States
Event ID
63189
Address
Route 120 And Wilson Rd
Code information
Lot #: C832840, Exp 02/13
Postal code
60073-9799
Report date
Oct 3, 2012
Product type
Drugs
Recall number
D-1687-2012
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
2,976 containers
Termination date
May 4, 2015
Reason for recall
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Voluntary / mandated
Voluntary: Firm initiated
Product description
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Sep 21, 2012
Initial firm notification
Letter
Center classification date
Sep 25, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1687-2012, published Oct 3, 2012. 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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