FDA recall D-1445-2012

Product

OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK

Reason for recall

CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation

Distribution

OK

Key facts

Status

Terminated

Initiation date

2012-06-21

Report date

2012-08-15

Termination date

2013-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norman, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1445-2012