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Recall Observatory FDA recall evidence

Drug product

Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

D-1430-2020

July 02, 2020

Class II

Product summary

Firm
MasterPharm LLC
Event
Event 85992
Status
Terminated
Classification
Class II
Quantity
288 tablets
Official record key
drug-enforcement:D-1430-2020

Official wording

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

Code information: 02-13-2020:83@8, BUD 8/11/2020 02-14-2020:64@11, BUD 8/12/2020

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