February 2016 FDA Recall Drug by Medical Park Homecare, Inc
D-0776-2016 - CGMP Deviations

This Class III drug recall was voluntarily initiated by Medical Park Homecare, Inc on February 5, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in U.S. Including: Oklahoma and the recall is currently terminated.

Recall Number: D-0776-2016

Reason for Recall
CGMP Deviations: Cylinders filled using out of date gauges.
Initiated
02-05-2016
Reported
03-23-2016
Quantity
a) 289 M6-Tank Cylinders, b) 49 D-Tank Cylinders, c) 743 E-Tank Cylinders.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73342
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medical Park Homecare, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: Oklahoma
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-23-2016
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 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.