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, Fa
Summary
The FDA issued a Class II for Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) by Family Medical Supply Inc. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0106-2024
Action Date
2023-11-22
Status
Terminated
Category
drug
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.
Lot/Code Info: All lots manufactured and distributed May 10, 2023, through October 31, 2023.
Quantity Affected: 26,657 Cylinders
Reason for Recall
cGMP Deviations
Distribution
Nationwide
Type: N/A
Recall Initiated: 2023-11-09
Company
Dunn, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Family Medical Supply Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Family Medical Supply Inc have FDA actions?
This is the only FDA action we have on record for Family Medical Supply Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0106-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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