FDA recall D-0779-2016

AGA Gas Inc · Class II · drug

Product

Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01

Reason for recall

cGMP Deviations; trailer may not have met GMP requirements prior to filling

Distribution

Product was delivered to Ohio

Key facts

Status
Terminated
Initiation date
2015-11-29
Report date
2016-03-30
Termination date
2017-12-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Independence, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0779-2016