Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20...
FDA Recall #D-1002-2019 — Class II — December 19, 2018
Product Description
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
Reason for Recall
CGMP Deviations
Recalling Firm
Roberts Home Medical LLC — Germantown, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9 Reservoirs
Distribution
Product was distributed in MD, VA and the District of Columbia
Code Information
Lot # 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518, 01002100318. No expiration date, but an evaporation rate of approximately 60 days from fill date depending on head pressure of reservoir.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated