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Recall Observatory FDA recall evidence

Drug product

Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

D-1426-2020

July 02, 2020

Class II

Product summary

Firm
MasterPharm LLC
Event
Event 85992
Status
Terminated
Classification
Class II
Quantity
1200 capsules
Official record key
drug-enforcement:D-1426-2020

Official wording

Reason: Lack of Processing Controls (lack of assurance of conformity to specifications).

Code information: 01-16-2020:70@11, BUD 7/14/2020 01-30-2020:87@9, BUD 7/28/2020

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls