FDA recall D-1060-2017
AtHome Medical, Inc. · Class II · drug
Product
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
Reason for recall
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Distribution
NJ
Key facts
- Status
- Terminated
- Initiation date
- 2017-05-11
- Report date
- 2017-08-16
- Termination date
- 2018-04-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Morris Plains, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1060-2017