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.

Recall Number: D-1083-2014

Firm: Bracco Diagnostics Inc

Classification: Class III

Status: Terminated

Report Date: 20140219

Initiation Date: 20131216

Termination Date: 20150123

Failed Stability Testing: This product is below specification for preservative content.

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.