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
Product summary
- 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
contaminated with benzene
-
Manufacturing or process control
CGMP Deviation