Why it was recalled
CGMP Deviations: Cylinders filled using out of date gauges.
Product description
Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
Lot numbers, UPCs & expiration codes
a) Lot #'s: 202166, 202167, 202168, 120164, 120165, 120166, 112161, 112162, 107161, 1230151, 1212151, 1212152, 1212153, 1208154, 1208155, 1208156, 1204152, 1204153, 1203151, 1116156, 1112151, 1112152. b) Lot #'s: 120164, 1212153, 1208154, 1204151, 1116156, 1112151. c) Lot #'s: 202161, 202162, 202163, 202164, 202165, 120161, 120162, 120163, 120164, 119161, 119162, 119163, 112163, 112164, 107162, 107163, 1230152, 1208151, 1208152, 1208153, 1204152, 1203152, 1203153, 1202151, 1202152, 1202153, 1125151, 1125152, 1116151, 1116152, 1116153, 1116154, 1116155, 1116156, 1112151, 1109151, 1109152, 1109153, 1109154, 1109155, 1109156, 1103151, 1103152, 1103153, 1103154, 1102151, 1102152, 1102153, 1102154.
Where it was sold
U.S. Including: 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-0776-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 5, 2016
- FDA report date
- Mar 23, 2016
- Quantity
- a) 289 M6-Tank Cylinders, b) 49 D-Tank Cylinders, c) 743 E-Tank Cylinders.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medical Park Homecare, Inc
Original FDA data
Every field from FDA enforcement report D-0776-2016, exactly as published.
Show all FDA fields
- City
- Bartlesville
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 73342
- Address
- 139 Se Katherine Ave
- Code information
- a) Lot #'s: 202166, 202167, 202168, 120164, 120165, 120166, 112161, 112162, 107161, 1230151, 1212151, 1212152, 1212153, 1208154, 1208155, 1208156, 1204152, 1204153, 1203151, 1116156, 1112151, 1112152. b) Lot #'s: 120164, 1212153, 1208154, 1204151, 1116156, 1112151. c) Lot #'s: 202161, 202162, 202163, 202164, 202165, 120161, 120162, 120163, 120164, 119161, 119162, 119163, 112163, 112164, 107162, 107163, 1230152, 1208151, 1208152, 1208153, 1204152, 1203152, 1203153, 1202151, 1202152, 1202153, 1125151, 1125152, 1116151, 1116152, 1116153, 1116154, 1116155, 1116156, 1112151, 1109151, 1109152, 1109153, 1109154, 1109155, 1109156, 1103151, 1103152, 1103153, 1103154, 1102151, 1102152, 1102153, 1102154.
- Postal code
- 74006-2316
- Report date
- Mar 23, 2016
- Product type
- Drugs
- Recall number
- D-0776-2016
- Classification
- Class III
- Recalling firm
- Medical Park Homecare, Inc
- Product quantity
- a) 289 M6-Tank Cylinders, b) 49 D-Tank Cylinders, c) 743 E-Tank Cylinders.
- Termination date
- Nov 23, 2016
- Reason for recall
- CGMP Deviations: Cylinders filled using out of date gauges.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
- Distribution pattern
- U.S. Including: Oklahoma
- Recall initiation date
- Feb 5, 2016
- Initial firm notification
- Telephone
- Center classification date
- Mar 15, 2016