Bracco Diagnostic Inc recalls E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Can…

Recall date

May 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1147-2015

FDA classification

Class III

Brand / firm

Bracco Diagnostic Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01