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Recall Observatory FDA recall evidence

Drug product

tabcin NOCHE; Capsules,12-count box, UPC 501008485033

D-1040-2016

May 11, 2016

Class II

Product summary

Firm
Profarma Distributors LLC
Event
Event 74135
Status
Terminated
Classification
Class II
Quantity
31 boxes ( 372 capsules)
Official record key
drug-enforcement:D-1040-2016

Official wording

Reason: CGMP Deviations

Code information: Lot # X223FS; Exp. 11/17

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations