D-914-2013 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2013
- Initiation Date
- July 19, 2013
- Termination Date
- January 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,096 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot #65846