Drug product
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
D-1083-2014
Product summary
- Event
- Event 67262
- Status
- Terminated
- Classification
- Class III
- Quantity
- 54,648 bottles
- Official record key
drug-enforcement:D-1083-2014
Official wording
Reason: Failed Stability Testing: This product is below specification for preservative content.
Code information: Lot #: 67603, Expiry: 2/2014
Distribution pattern: Nationwide including Puerto Rico
Derived failure modes
-
Unknown
Failed Stability Testing: This product is below specification for preservative content.