Drug product
Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2
D-0250-2024
Product summary
- Event
- Event 89106
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-0250-2024
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