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Recall Observatory FDA recall evidence

Drug product

1% Clotrimazol cream, 30 mg tube, UPC 501318644335

D-1043-2016

May 11, 2016

Class II

Product summary

Firm
Profarma Distributors LLC
Event
Event 74135
Status
Terminated
Classification
Class II
Quantity
79 boxes (79 tubes)
Official record key
drug-enforcement:D-1043-2016

Official wording

Reason: CGMP Deviations

Code information: Lot # GRU1390; Exp. 08/17

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations