Dextrose Injection, Solution
FDA Recall NDC 0338-0719
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dextrose (NDC 0338-0719). A significant event, classified as Class I, was initiated on Dec 15, 2015 by Baxter Healthcare Corporation. The reported reason for this action was: "Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Dec 15, 2015
Jun 15, 2016
28,080 VIAFLEX Plastic Containers
Recall Profile & Regulatory Data
Event ID
72816
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 15, 2022
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
Batch or Lot Expiration Information
Lot# C985150; Exp. 07/16
Affected Packages Involved in this Recall
0338-0719-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
