PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: February 19, 2014 Initiated: December 16, 2013 #D-1083-2014

Product Description

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.

Reason for Recall

Failed Stability Testing: This product is below specification for preservative content.

Details

Recalling Firm
Bracco Diagnostics Inc
Units Affected
54,648 bottles
Distribution
Nationwide including Puerto Rico
Location
Monroe Township, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bracco Diagnostics Inc. Units affected: 54,648 bottles.
Why was this product recalled?
Failed Stability Testing: This product is below specification for preservative content.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2014. Severity: Low. Recall number: D-1083-2014.