PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 15, 2012 Initiated: June 21, 2012 #D-1445-2012

Product Description

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

Details

Units Affected
861 cylinders
Distribution
OK
Location
Norman, OK

Frequently Asked Questions

What product was recalled?
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. Recalled by Oklahoma Respiratory Care Inc. Units affected: 861 cylinders.
Why was this product recalled?
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Which agency issued this recall?
This recall was issued by the FDA Drug on August 15, 2012. Severity: Moderate. Recall number: D-1445-2012.