Bracco Diagnostics Inc Product 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.

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.

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Bracco Diagnostics Inc. Recalls

Recall Summary

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

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

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

Gastrografin (Bracco Diagnostics) – Foreign Substance Risk (2013)

Cardiogen-82 (Bracco Diagnostics) – Sr-82 level deviation (2012)

Multihance Injection (Bracco) – Sterility Concern (2012)

Multihance Injection (Bracco) – Short Fill Potential (2012)