Drug 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
D-1147-2015
Product summary
- Event
- Event 71442
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1008 boxes
- Official record key
drug-enforcement:D-1147-2015
Official wording
Reason: Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Code information: Lot #: 00513716, 00514712, Exp 03/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification