FDA recall D-1536-2014

Product

E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.

Reason for recall

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-07-02

Report date

2014-08-20

Termination date

2015-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1536-2014