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Recall Observatory FDA recall evidence

Drug product

Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

D-1177-2020

April 06, 2020

Class II

Product summary

Firm
The Medicine Shoppe Pharmacy
Event
Event 85404
Status
Terminated
Classification
Class II
Quantity
1 tube
Official record key
drug-enforcement:D-1177-2020

Official wording

Reason: Lack of Processing Control

Code information: Lot: 45044 Discard by: 8/2/2020

Distribution pattern: Florida

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Control