D-0609-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 4, 2018
- Initiation Date
- March 8, 2018
- Termination Date
- March 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,136 tubes
Product Description
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
Reason for Recall
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Distribution Pattern
Product was distributed throughout the United States, Hong Kong and New Zealand.
Code Information
Lot # 00538529