Bracco Diagnostic Inc recalls E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiar
Recalled August 20, 2014 · FDA recall D-1536-2014 · Bracco Diagnostic
Hazard
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months. · FDA Class III
Units
216,792 bottles
Sold at
Nationwide and Puerto Rico
Description
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Product
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.
Manufacturer(s)
Bracco Diagnostic Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →