FDA recall D-0355-2021

Grace Healthcare Medical, Inc · Class II · drug

Product

Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331

Reason for recall

cGMP deviations

Distribution

USA Nationwide

Key facts

Status: Terminated
Initiation date: 2021-04-15
Report date: 2021-05-05
Termination date: 2022-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gulfport, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0355-2021