FDA recall D-914-2013

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-07-19

Report date

2013-08-28

Termination date

2015-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-914-2013