FDA-Drug2018-04-04Class II
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
Bracco Diagnostics Inc.
Hazard
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Sold states
Product was distributed throughout the United States, Hong Kong and New Zealand.
Affected count
2,136 tubes
Manufactured in
259 Prospect Plains Rd Bldg H, Monroe Township, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0609-2018Don't want to check this manually?
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