Recalls / Class III
Class IIID-1083-2014
Product
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.
- Affected lot / code info
- Lot #: 67603, Expiry: 2/2014
Why it was recalled
Failed Stability Testing: This product is below specification for preservative content.
Recalling firm
- Firm
- Bracco Diagnostics Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Rd., Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 54,648 bottles
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2013-12-16
- FDA classified
- 2014-02-07
- Posted by FDA
- 2014-02-19
- Terminated
- 2015-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1083-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.