Drug recall D-1083-2014

Class III Terminated reported Feb 19, 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.

Reason for recall

Failed Stability Testing: This product is below specification for preservative content.

Lots and codes

Lot #: 67603, Expiry: 2/2014

Recall details

Recalling firm
Bracco Diagnostics Inc, Monroe Township, NJ
Quantity
54,648 bottles
Distribution
Nationwide including Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
December 16, 2013
Terminated
January 23, 2015