Reported Aug 20, 2014 · Terminated
E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a…
Bracco Diagnostic Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 Diagnostic Inc · 259 Prospect Plains Road · Monroe Township, NJ · 08831
Is this the product you have?
- 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.
- Lot codes and dates
Lot #'s: 642056420664200642016420264203642046420764264Exp 05/156426564267642686427064271Exp 06/15
- Amount recalled
- 216,792 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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