Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Grace Healthcare Medical, Inc

Origin

MS, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0355-2021

Other Oxygen recalls

See all

Class II · Moderate risk Terminated Nov 9, 2023

Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family…

Reason cGMP Deviations

Family Medical Supply Inc D-0106-2024

Class II · Moderate risk Terminated Dec 19, 2018

Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical…

Reason CGMP Deviations

Roberts Home Medical LLC D-1002-2019

Class II · Moderate risk Terminated May 11, 2017

Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.

Reason GMP Deviations: The firm does not include an SOP for testing for out of specifications.

AtHome Medical, Inc. D-1060-2017

Class II · Moderate risk Terminated Jul 5, 2016

Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by…

Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal…

Let's Talk Health, Inc. D-1452-2016

Class III · Low risk Terminated Feb 5, 2016

Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx…

Reason CGMP Deviations: Cylinders filled using out of date gauges.

Medical Park Homecare, Inc D-0776-2016