PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: August 20, 2014 Initiated: July 2, 2014 #D-1536-2014

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Bracco Diagnostic Inc
Units Affected
216,792 bottles
Distribution
Nationwide and Puerto Rico
Location
Monroe Township, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bracco Diagnostic Inc. Units affected: 216,792 bottles.
Why was this product recalled?
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 20, 2014. Severity: Low. Recall number: D-1536-2014.