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Recall Observatory FDA recall evidence

Drug product

Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical Spray Can, Net WT 3.8 oz (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC 69423-386-10, UPC 0 37000 73034 7 OR UPC 0 12044 04475 9 (12 Pack, older label)

D-0239-2024

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-0239-2024

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