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.
Reported: August 20, 2014 Initiated: July 2, 2014 #D-1536-2014
Product Description
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.
Reason for Recall
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Details
- Recalling Firm
- Bracco Diagnostic Inc
- Units Affected
- 216,792 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Monroe Township, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bracco Diagnostic Inc. Units affected: 216,792 bottles.
Why was this product recalled? ▼
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 20, 2014. Severity: Low. Recall number: D-1536-2014.
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