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Recall Observatory FDA recall evidence

Drug product

Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 Topical spray cans, each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Dist. by: Procter & Gamble, Cincinnati, OH 45202,

D-0253-2024

November 23, 2021

Class II

Product summary

Firm
The Procter & Gamble Company
Event
Event 89106
Status
Terminated
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-0253-2024

Official wording

Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene

Code information: All lots with expiry through September 2023

Distribution pattern: Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contaminated with benzene
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation