December 2018 FDA Recall Drug by Roberts Home Medical Llc
D-1002-2019 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Roberts Home Medical Llc on December 19, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed in MD, VA and the District of Columbia and the recall is currently terminated.

Recall Number: D-1002-2019

Reason for Recall
CGMP Deviations
Initiated
12-19-2018
Reported
03-20-2019
Quantity
9 Reservoirs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82305
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Roberts Home Medical LLC
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.
Product was distributed in MD, VA and the District of Columbia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2019
Product Description About Product Description
Full technical description of the product.
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875

Batch or Lot Expiration 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.