FDA recall D-0782-2016

Product

UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.

Reason for recall

CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-16

Report date

2016-04-06

Termination date

2016-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danbury, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0782-2016