May 2017 FDA Recall Drug by Athome Medical, Inc.
D-1060-2017 - GMP Deviations

This Class II drug recall was voluntarily initiated by Athome Medical, Inc. on May 11, 2017 for the product Drug. The FDA reported the reason for recall as gmp deviations. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-1060-2017

Reason for Recall
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Initiated
05-11-2017
Reported
08-16-2017
Quantity
80 lbs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77760
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.
AtHome Medical, Inc.
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.
Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2018
Product Description About Product Description
Full technical description of the product.
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.

Batch or Lot Expiration Information

Lot# B-06324027 (AHM #E040645)
Lot# : 051017V1, Exp. Date: 5/11/17