FDAClass IIApril 4, 2018

E-Z-Paste Barium Sulfate Esophageal Cream recall

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…

Why was E-Z-Paste Barium Sulfate Esophageal Cream recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 00538529

Product
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…
Recalling firm
Bracco Diagnostics Inc.
Quantity
2,136 tubes
Distribution
Product was distributed throughout the United States, Hong Kong and New Zealand.
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls