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
- Recalling Firm
- Oklahoma Respiratory Care Inc
- 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.
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