Reported Feb 19, 2014 · Terminated
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a…
Bracco Diagnostics 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 Diagnostics Inc · 259 Prospect Plains Rd. · Monroe Township, NJ · 08831
Is this the product you have?
- VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
- Lot codes and dates
- Lot #: 67603
- Expiry2/2014
- Amount recalled
- 54,648 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Stability Testing: This product is below specification for preservative content.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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