RecallRadar

FDA Drug recall D-0355-2021

Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder

On 2021-05-05 the FDA classified a Class II recall of Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder by Grace Healthcare Medical, citing cGMP deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0355-2021
ClassificationClass II
Statusterminated
Initiated2021-04-15
Published2021-05-05
Last updated2026-09-13 11:52 UTC
CompanyGrace Healthcare Medical
DistributionUS

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

cGMP deviations

Identifiers

code_infoAll lots manufactured and distributed 04/01/2019-04/09/2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0355-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.