Drug Enforcement D-0106-2024

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

November 22, 2023

Termination Date

August 8, 2025

Product Information

Product description
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
Product quantity
26,657 Cylinders
Reason for recall
cGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Family Medical Supply Inc
Address
2011 W Cumberland St, N/A

United States
Voluntary / Mandated
N/A
Status date
—

Codes & Dates

Recall number
D-0106-2024
Event ID
93418
Recall initiation date
November 9, 2023
Center classification date
November 16, 2023
Code info
All lots manufactured and distributed May 10, 2023, through October 31, 2023.
More code info
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