Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107
Summary
The FDA issued a Class II for Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-P by The Procter & Gamble Company. Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene.
Details
Source
Drug Recall
External ID
D-0252-2024
Action Date
2024-01-24
Status
Terminated
Category
drug
Product Description
Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9
Lot/Code Info: All lots with expiry through September 2023
Quantity Affected: unknown
Reason for Recall
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-23
Company
Cincinnati, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Procter & Gamble Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Procter & Gamble Company have FDA actions?
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0252-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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