Oxygen recalled over manufacturing violations

Recall date

February 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medical Park Homecare, Inc recalls Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tan…

Recall number

D-0776-2016

FDA classification

Class III

Brand / firm

Medical Park Homecare, Inc

Sold / distributed

U.S. Including: Oklahoma

Why it was recalled

CGMP Deviations: Cylinders filled using out of date gauges.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.