Drug product
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
D-1002-2019
Product summary
- Event
- Event 82305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 Reservoirs
- Official record key
drug-enforcement:D-1002-2019
Official wording
Reason: CGMP Deviations
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.
Distribution pattern: Product was distributed in MD, VA and the District of Columbia
Derived failure modes
-
Manufacturing or process control
CGMP Deviations