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
Reported: April 4, 2018 Initiated: March 8, 2018 #D-0609-2018
Product Description
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
Reason for Recall
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Details
- Recalling Firm
- Bracco Diagnostics Inc.
- Units Affected
- 2,136 tubes
- Distribution
- Product was distributed throughout the United States, Hong Kong and New Zealand.
- Location
- Monroe Township, NJ
Frequently Asked Questions
What product 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. Recalled by Bracco Diagnostics Inc.. Units affected: 2,136 tubes.
Why was this product recalled? ▼
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 4, 2018. Severity: Moderate. Recall number: D-0609-2018.
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