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Class I: serious health riskTerminated

Baxter Healthcare 10% Dextrose Injection Recall

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Health…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class I
Reported by FDA
Jul 15, 2015
Recall ID
D-1210-2015
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 10% Dextrose Injection starting Mar 24, 2015. The FDA classified it as Class I (serious health risk) and published enforcement report D-1210-2015 on Jul 15, 2015. Reason: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal). Status: Terminated.

Why it was recalled

Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Product description

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02

Lot numbers, UPCs & expiration codes

Lot #: C965558 and C963520, Exp 7/31/2016

Where it was sold

US, Puerto Rico, and Bermuda

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-1210-2015
Classification
Class I
Status
Terminated
Recall initiated
Mar 24, 2015
FDA report date
Jul 15, 2015
Quantity
18,324 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-1210-2015, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
70926
Address
1 Baxter Pkwy
Code information
Lot #: C965558 and C963520, Exp 7/31/2016
Postal code
60015-4625
Report date
Jul 15, 2015
Product type
Drugs
Recall number
D-1210-2015
Classification
Class I
Recalling firm
Baxter Healthcare Corp.
Product quantity
18,324 bags
Termination date
Feb 7, 2017
Reason for recall
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Voluntary / mandated
Voluntary: Firm initiated
Product description
10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02
Distribution pattern
US, Puerto Rico, and Bermuda
Recall initiation date
Mar 24, 2015
Initial firm notification
Letter
Center classification date
Jul 6, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1210-2015, published Jul 15, 2015. 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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