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Recall Observatory FDA recall evidence

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

December 19, 2018

Class II

Product summary

Firm
Roberts Home Medical LLC
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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations