Bracco Diagnostics Inc. recalls 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
Recalled April 4, 2018 · FDA recall D-0609-2018 · Bracco Diagnostics
Hazard
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot. · FDA Class II
Units
2,136 tubes
Sold at
Product was distributed throughout the United States, Hong Kong and New Zealand.
Description
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
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
Manufacturer(s)
Bracco Diagnostics Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →