5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx onl...
FDA Recall #D-1688-2012 — Class II — September 21, 2012
Product Description
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
Reason for Recall
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Recalling Firm
Baxter Healthcare Corp. — Round Lake, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,064 containers
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: C828814, Exp 12/12; C841551, Exp 04/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated