Why it was recalled
CGMP Deviations
Product description
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
Lot numbers, UPCs & expiration codes
Lot # 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518, 01002100318. No expiration date, but an evaporation rate of approximately 60 days from fill date depending on head pressure of reservoir.
Where it was sold
Product was distributed in MD, VA and the District of Columbia
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-1002-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 19, 2018
- FDA report date
- Mar 20, 2019
- Quantity
- 9 Reservoirs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Roberts Home Medical LLC
Original FDA data
Every field from FDA enforcement report D-1002-2019, exactly as published.
Show all FDA fields
- City
- Germantown
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82305
- Address
- 20465 Seneca Meadows Pkwy
- Code information
- Lot # 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518, 01002100318. No expiration date, but an evaporation rate of approximately 60 days from fill date depending on head pressure of reservoir.
- Postal code
- 20876-7005
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-1002-2019
- Classification
- Class II
- Recalling firm
- Roberts Home Medical LLC
- Product quantity
- 9 Reservoirs
- Termination date
- May 1, 2019
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
- Distribution pattern
- Product was distributed in MD, VA and the District of Columbia
- Recall initiation date
- Dec 19, 2018
- Initial firm notification
- Telephone
- Center classification date
- Mar 14, 2019