Drug 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
D-914-2013
Product summary
- Event
- Event 66032
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,096 bottles
- Official record key
drug-enforcement:D-914-2013
Official wording
Reason: Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Code information: Lot #65846
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications