E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.

Recall Number: D-1536-2014

Firm: Bracco Diagnostic Inc

Classification: Class III

Status: Terminated

Report Date: 20140820

Initiation Date: 20140702

Termination Date: 20150630

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.