PlainRecalls
FDA Drug Low Class III Terminated

Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53

Reported: August 28, 2013 Initiated: July 19, 2013 #D-914-2013

Product Description

Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53

Reason for Recall

Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Details

Recalling Firm
Bracco Diagnostics Inc
Units Affected
3,096 bottles
Distribution
Nationwide
Location
Monroe Township, NJ

Frequently Asked Questions

What product was recalled?
Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53. Recalled by Bracco Diagnostics Inc. Units affected: 3,096 bottles.
Why was this product recalled?
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 28, 2013. Severity: Low. Recall number: D-914-2013.