D-1083-2014 Class III Terminated
FDA drug recall D-1083-2014 was initiated by Bracco Diagnostics Inc on December 16, 2013 and is designated Class III. Reason for recall: Failed Stability Testing: This product is below specification for preservative content. The recall status is terminated (terminated January 23, 2015). Affected quantity: 54,648 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2014
- Initiation Date
- December 16, 2013
- Termination Date
- January 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,648 bottles
Product Description
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.
Reason for Recall
Failed Stability Testing: This product is below specification for preservative content.
Distribution Pattern
Nationwide including Puerto Rico
Code Information
Lot #: 67603, Expiry: 2/2014