D-1147-2015 Class III Terminated
FDA drug recall D-1147-2015 was initiated by Bracco Diagnostic Inc on May 27, 2015 and is designated Class III. Reason for recall: Failed stability specifications:This recall has been initiated due to out of specification results for viscosity. The recall status is terminated (terminated February 19, 2016). Affected quantity: 1008 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2015
- Initiation Date
- May 27, 2015
- Termination Date
- February 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1008 boxes
Product Description
E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
Reason for Recall
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Distribution Pattern
Nationwide
Code Information
Lot #: 00513716, 00514712, Exp 03/2016