D-1002-2019 Class II Terminated
FDA drug recall D-1002-2019 was initiated by Roberts Home Medical LLC on December 19, 2018 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated May 1, 2019). Affected quantity: 9 Reservoirs.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2019
- Initiation Date
- December 19, 2018
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 Reservoirs
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
Reason for Recall
CGMP Deviations
Distribution Pattern
Product was distributed in MD, VA and the District of Columbia
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.