FDA-Drug2014-02-19Class III
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.
Bracco Diagnostics Inc
Hazard
Failed Stability Testing: This product is below specification for preservative content.
Sold states
Nationwide including Puerto Rico
Affected count
54,648 bottles
Manufactured in
259 Prospect Plains Rd., Building H, Monroe Township, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2014Don't want to check this manually?
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