Drug product
E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.
D-1536-2014
Product summary
- Event
- Event 68812
- Status
- Terminated
- Classification
- Class III
- Quantity
- 216,792 bottles
- Official record key
drug-enforcement:D-1536-2014
Official wording
Reason: Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Code information: Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent