Why it was recalled
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Product description
Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071
Lot numbers, UPCs & expiration codes
Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.
Where it was sold
Oklahoma
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-818-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 5, 2012
- FDA report date
- Jul 31, 2013
- Quantity
- 94 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Oklahoma Respiratory Care Inc
Original FDA data
Every field from FDA enforcement report D-818-2013, exactly as published.
Show all FDA fields
- City
- Norman
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 65621
- Address
- 623 N Porter Ave Ste 100
- Code information
- Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.
- Postal code
- 73071-6000
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-818-2013
- Classification
- Class II
- Recalling firm
- Oklahoma Respiratory Care Inc
- Product quantity
- 94 cylinders
- Termination date
- Nov 4, 2014
- Reason for recall
- Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071
- Distribution pattern
- Oklahoma
- Recall initiation date
- Dec 5, 2012
- Initial firm notification
- Visit
- Center classification date
- Jul 24, 2013