Drug product
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
D-0958-2016
Product summary
- Event
- Event 72816
- Status
- Terminated
- Classification
- Class I
- Quantity
- 28,080 VIAFLEX Plastic Containers
- Official record key
drug-enforcement:D-0958-2016
Official wording
Reason: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Code information: Lot # C985150; Exp. 07/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter