E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube recall — FDA D-0609-2018
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Overview of recall records associated with Bracco Diagnostics Inc., including dates, categories and classifications where available.
Classification mix: Class II: 4, Class III: 2.
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Failed Stability Testing: This product is below specification for preservative content.
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Presence of foreign substance: One lot of the product may contain black foreign particles
GMP deviation; Sr-82 levels exceeded alert limit specification
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
This page summarizes recall records in which the official source identifies Bracco Diagnostics Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.