Recalls / Class III
Class IIID-1147-2015
Product
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
- Affected lot / code info
- Lot #: 00513716, 00514712, Exp 03/2016
Why it was recalled
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Recalling firm
- Firm
- Bracco Diagnostic Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Road, Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 1008 boxes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-05-27
- FDA classified
- 2015-06-22
- Posted by FDA
- 2015-07-01
- Terminated
- 2016-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1147-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.