Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53

Recall Number: D-914-2013

Firm: Bracco Diagnostics Inc

Classification: Class III

Status: Terminated

Report Date: 20130828

Initiation Date: 20130719

Termination Date: 20150129

Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53