VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by...
FDA Recall #D-1083-2014 — Class III — December 16, 2013
Product Description
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
Reason for Recall
Failed Stability Testing: This product is below specification for preservative content.
Recalling Firm
Bracco Diagnostics Inc — Monroe Township, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
54,648 bottles
Distribution
Nationwide including Puerto Rico
Code Information
Lot #: 67603, Expiry: 2/2014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated