Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc…

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

Recalling firm

Roberts Home Medical LLC

Origin

MD, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1002-2019

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 Apr 15, 2021

Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D…

Reason cGMP deviations

Grace Healthcare Medical, Inc D-0355-2021

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Reason CGMP Deviations: Cylinders filled using out of date gauges.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