Why it was recalled
cGMP deviations
Product description
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
Lot numbers, UPCs & expiration codes
All lots manufactured and distributed 04/01/2019-04/09/2021
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0355-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 15, 2021
- FDA report date
- May 5, 2021
- Quantity
- 35,838 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Grace Healthcare Medical, Inc
Original FDA data
Every field from FDA enforcement report D-0355-2021, exactly as published.
Show all FDA fields
- City
- Gulfport
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 87742
- Address
- 1418 31st Ave
- Code information
- All lots manufactured and distributed 04/01/2019-04/09/2021
- Postal code
- 39501-2746
- Report date
- May 5, 2021
- Product type
- Drugs
- Recall number
- D-0355-2021
- Classification
- Class II
- Recalling firm
- Grace Healthcare Medical, Inc
- Product quantity
- 35,838 cylinders
- Termination date
- Dec 2, 2022
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Apr 15, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 26, 2021