Reported Apr 4, 2018 · Terminated
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…
Bracco Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bracco Diagnostics Inc. · 259 Prospect Plains Rd Bldg H · Monroe Township, NJ · 08831-3820
Is this the product you have?
- 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
- Lot codes and dates
- Lot # 00538529
- Amount recalled
- 2,136 tubes
Why it was recalled
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
This product could cause temporary or reversible health problems — stop using it.
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