Unapproved New Drugs/Misbranded
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AlzClipp / UniUni – 711274 – 07/29/2025
Unapproved New Drugs/MisbrandedFagron Compounding Services. Wichita, KS. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Fagron Compounding Services. Wichita, KS. 483 issued 08/08/2025
FEI Number 3012104093
Firm Name Fagron Compounding Services
Record Type 483
State KSCharles H. Harper, M.D. Norfolk, NE. EIR issued 11/13/2020
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/13/2020
Short Title (70 char) Charles H. Harper, M.D. Norfolk, NE. EIR issued 11/13/2020
FEI Number 3015685119
Firm Name Charles H. Harper, M.D.
Record Type EIR
State NE
Establishment Type Clinical InvestigatMeridian Medical Technologies a Pfizer Company, St. Louis, MO, 483 Issued 10/9/2013
Meridian Medical Technologies a Pfizer Company, St. Louis, MO, 483 Issued 10/9/2013FDA Rationale for Recognition Decision: Isavuconazonium sulfate
FDA Rationale for Recognition Decision: Isavuconazonium sulfateAspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning Letter About Internal Processes and Distal Tip Characteristics
The Hippo 072 Aspiration System is used to remove stroke-causing clots but there may be issues with the distal tip during clot removal.