FDA recall D-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.

Reason for recall

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

Distribution

Nationwide including Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-12-16

Report date

2014-02-19

Termination date

2015-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2014