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Recall Observatory FDA recall evidence

Drug product

tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057

D-1039-2016

May 11, 2016

Class II

Product summary

Firm
Profarma Distributors LLC
Event
Event 74135
Status
Terminated
Classification
Class II
Quantity
42 boxes (504 capsules)
Official record key
drug-enforcement:D-1039-2016

Official wording

Reason: CGMP Deviations

Code information: Lot # 224TS; Exp. 02/17

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations