5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Health...
FDA Recall #D-1162-2014 — Class I — November 21, 2013
Product Description
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.
Reason for Recall
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
Recalling Firm
Baxter Healthcare Corp. — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
105,216 containers
Distribution
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Code Information
Lot #: P285288, Exp 11/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated