Status
Terminated
Drug Enforcement D-1445-2012
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Classification
Class II
Report Date
August 15, 2012
Termination Date
August 2, 2013
Product Information
- 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
- Product quantity
- 861 cylinders
- Reason for recall
- CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
- Recall initiation reason
- —
- Initial firm notification
- Visit
- Distribution pattern
- OK
Location & Firm
- Recalling firm
- Oklahoma Respiratory Care Inc
- Address
-
623 N Porter Ave Ste 100
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1445-2012
- Event ID
- 62698
- Recall initiation date
- June 21, 2012
- Center classification date
- August 8, 2012
- Code info
- All lots distributed January 1, 2011 - October 18, 2011.
- More code info
- —