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…

Recall date

March 8, 2018

Source

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

Recall number

D-0609-2018

FDA classification

Class II

Brand / firm

Bracco Diagnostics Inc.

Sold / distributed

Product was distributed throughout the United States, Hong Kong and New Zealand.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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