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.

FDA recall notice · announced February 19, 2014 · Bracco Diagnostics

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide including Puerto Rico
Lot/code information: Lot #: 67603, Expiry: 2/2014
Quantity: 54,648 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1083-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.