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Class I: serious health riskTerminated

Baxter Healthcare Dextrose Injection Recall

Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class I
Reported by FDA
Jun 15, 2016
Recall ID
D-0958-2016
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled Dextrose Injection starting Dec 15, 2015. The FDA classified it as Class I (serious health risk) and published enforcement report D-0958-2016 on Jun 15, 2016. Reason: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

Product description

Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06

Lot numbers, UPCs & expiration codes

Lot # C985150; Exp. 07/16

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-0958-2016
Classification
Class I
Status
Terminated
Recall initiated
Dec 15, 2015
FDA report date
Jun 15, 2016
Quantity
28,080 VIAFLEX Plastic Containers
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-0958-2016, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
72816
Address
1 Baxter Pkwy
Code information
Lot # C985150; Exp. 07/16
Postal code
60015-4625
Report date
Jun 15, 2016
Product type
Drugs
Recall number
D-0958-2016
Classification
Class I
Recalling firm
Baxter Healthcare Corp.
Product quantity
28,080 VIAFLEX Plastic Containers
Termination date
Apr 15, 2022
Reason for recall
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06
Distribution pattern
Nationwide
Recall initiation date
Dec 15, 2015
Initial firm notification
Letter
Center classification date
Jun 6, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0958-2016, published Jun 15, 2016. 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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