Drug product
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
D-0609-2018
Product summary
- Event
- Event 79481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,136 tubes
- Official record key
drug-enforcement:D-0609-2018
Official wording
Reason: Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Code information: Lot # 00538529
Distribution pattern: Product was distributed throughout the United States, Hong Kong and New Zealand.
Derived failure modes
-
Potency or specification failure
Out-of-specification