D-0958-2016 Class I Terminated
FDA drug recall D-0958-2016 was initiated by Baxter Healthcare Corp. on Dec 15, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. The recall status is terminated (terminated Apr 15, 2022). Affected quantity: 28,080 VIAFLEX Plastic Containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 15, 2016
- Initiation Date
- Dec 15, 2015
- Termination Date
- Apr 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,080 VIAFLEX Plastic Containers
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
Reason for Recall
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Distribution Pattern
Nationwide
Code Information
Lot # C985150; Exp. 07/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0958-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026