5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6...
FDA Recall #D-1686-2012 — Class II — September 21, 2012
Product Description
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
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
753,941 containers
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: a) C841114, C841254, Exp 09/12; C842229, C842898, C843037, C843326, C844209, Exp 10/12; C844456, C844928, C846089, C846246, C847178, Exp 11/12; C848044, C848804, C849869, C849810, C850313, Exp 12/12; C852574, C852673, C853168, C853275, C853473, Exp 01/13; C854331, C855098, C855551, Exp 02/13; C856690, C856815, C857813, Exp 03/13; C858829, C858951, C859884, C860049, C860304, C860304A, C860452, C861138, Exp 04/13; C861252, C861971, C862748, C862854, Exp 05/13; C865576, C865683, C866079, Exp 06/13; C866947, C867283, C867424, C867960, C868455, Exp 07/13; b) C818039, Exp 09/12; C821793, Exp 10/12; C824276, C825679, Exp 11/12; C828350, Exp 12/12; C830323, C832105, Exp 01/13; C834986, C836114, Exp 03/13; C840736, Exp 04/13; C843433, Exp 05/13; C844829, C845784, Exp 06/13; C848333, C850446, C850446A, Exp 07/13; C852376, C852939, Exp 08/13; C856443, C857417, C857656, C858381, Exp 10/13; C858498, C859470, C859652, Exp 11/13; C863365, Exp 12/13; C863738, C863852, C865451, C866392, Exp 01/14; C867846, Exp 02/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated