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Recall Observatory FDA recall evidence

Drug product

Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

D-1218-2020

April 06, 2020

Class II

Product summary

Firm
The Medicine Shoppe Pharmacy
Event
Event 85404
Status
Terminated
Classification
Class II
Quantity
1 jar
Official record key
drug-enforcement:D-1218-2020

Official wording

Reason: Lack of Processing Control

Code information: Lot: 44518 Discard by: 3/15/2020

Distribution pattern: Florida

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Control