FDAFDA · Food and drugs·Recall number D-0609-2018
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
Published April 4, 2018 · Recall initiated: March 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- E-Z-PASTE
- Manufacturer
- Bracco Diagnostics Inc.
- Distributor
- Product was distributed throughout the United States, Hong Kong and New Zealand.
- Lot
- Lot # 00538529
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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