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
- Company
- Bracco Diagnostics Inc
- Recall Initiated
- July 19, 2013
- Posted
- August 28, 2013
- Recall Number
- D-914-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,096 bottles
- Firm Location
- Monroe Township, NJ, United States
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
Lot / Code Info
Lot #65846
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