FDAFDA · Food and drugs·Recall number D-1083-2014
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.
Published February 19, 2014 · Recall initiated: December 16, 2013
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 Testing: This product is below specification for preservative content.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bracco Diagnostics Inc
- Distributor
- Nationwide including Puerto Rico
- Lot
- Lot #: 67603, Expiry: 2/2014
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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