Oxygen recalled over manufacturing violations
- Recall date
- April 15, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Grace Healthcare Medical, Inc recalls Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinde…
- Recall number
- D-0355-2021
- FDA classification
- Class II
- Brand / firm
- Grace Healthcare Medical, Inc
- Sold / distributed
- USA Nationwide
Why it was recalled
cGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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