D-0776-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 23, 2016
- Initiation Date
- February 5, 2016
- Termination Date
- November 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 289 M6-Tank Cylinders, b) 49 D-Tank Cylinders, c) 743 E-Tank Cylinders.
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.
Reason for Recall
CGMP Deviations: Cylinders filled using out of date gauges.
Distribution Pattern
U.S. Including: Oklahoma
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.