Bracco Diagnostics Inc. Recalls

All product recalls associated with Bracco Diagnostics Inc..

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Recall Summary

Total Recalls

13

Past Year

0

Class I (Serious)

2

Most Recent

Mar 2018

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–13 of 13 recalls

E-Z-Paste Barium Cream (Bracco) – Preservative Assay (2018)

Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

Class IIModerate

FDAMar 8, 2018Nationwide• Bracco Diagnostics Inc.

E-Z-CAT Dry (Bracco Diagnostic) – viscosity specification (2015)

Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.

Class IIILow

FDAMay 27, 2015Nationwide• Bracco Diagnostic Inc

E-Z-Gas Effervescent Granules (Bracco) – Subpotent Drug (2014)

Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

Class III

Low

FDASep 18, 2014Nationwide• Bracco Diagnostic Inc

E-Z-HD Barium Sulfate (Bracco) – Subpotent Drug Concerns (2014)

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Class IIILow

FDAJul 2, 2014Nationwide• Bracco Diagnostic Inc

VoLumen Barium Suspension (Bracco) – Preservative Issue (2013)

Failed Stability Testing: This product is below specification for preservative content.

Class IIILow

FDADec 16, 2013Nationwide• Bracco Diagnostics Inc

Tagitol V Barium Sulfate (Bracco) – Failed Stability Test (2013)

Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Class IIILow

FDAJul 19, 2013Nationwide• Bracco Diagnostics Inc