FDA-Drug2014-08-20Class III
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.
Bracco Diagnostic Inc
Hazard
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Sold states
Nationwide and Puerto Rico
Affected count
216,792 bottles
Manufactured in
259 Prospect Plains Road, Building H, Monroe Township, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1536-2014Don't want to check this manually?
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