Drug product
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
D-1162-2014
Product summary
- Event
- Event 67092
- Status
- Terminated
- Classification
- Class I
- Quantity
- 105,216 containers
- Official record key
drug-enforcement:D-1162-2014
Official wording
Reason: Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Code information: Lot #: P285288, Exp 11/13
Distribution pattern: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter