D-1445-2012 Class II Terminated
FDA drug recall D-1445-2012 was initiated by Oklahoma Respiratory Care Inc on June 21, 2012 and is designated Class II. Reason for recall: CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation The recall status is terminated (terminated August 2, 2013). Affected quantity: 861 cylinders.
Recall Details
- Product Type
- Drugs
- Report Date
- August 15, 2012
- Initiation Date
- June 21, 2012
- Termination Date
- August 2, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 861 cylinders
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
Distribution Pattern
OK
Code Information
All lots distributed January 1, 2011 - October 18, 2011.