Why it was recalled
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
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
Lot numbers, UPCs & expiration codes
All lots distributed January 1, 2011 - October 18, 2011.
Where it was sold
OK
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1445-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 21, 2012
- FDA report date
- Aug 15, 2012
- Quantity
- 861 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Oklahoma Respiratory Care Inc
Original FDA data
Every field from FDA enforcement report D-1445-2012, exactly as published.
Show all FDA fields
- City
- Norman
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 62698
- Address
- 623 N Porter Ave Ste 100
- Code information
- All lots distributed January 1, 2011 - October 18, 2011.
- Postal code
- 73071-6000
- Report date
- Aug 15, 2012
- Product type
- Drugs
- Recall number
- D-1445-2012
- Classification
- Class II
- Recalling firm
- Oklahoma Respiratory Care Inc
- Product quantity
- 861 cylinders
- Termination date
- Aug 2, 2013
- Reason for recall
- CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- OK
- Recall initiation date
- Jun 21, 2012
- Initial firm notification
- Visit
- Center classification date
- Aug 8, 2012