FDAFDA · Food and drugs·Recall number D-1536-2014
E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.
Published August 20, 2014 · Recall initiated: July 2, 2014
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
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- E-Z-HD
- Manufacturer
- Bracco Diagnostic Inc
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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