Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Uni
Summary
The FDA issued a Class II for Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydr by Unilever United States Inc.. 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-0211-2024
Action Date
2022-05-04
Status
Ongoing
Category
drug
Product Description
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3
Lot/Code Info: all lots, expiry 9/30/2023
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 in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-30
Company
Englewood Cliffs, NJ
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 121 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Unilever United States Inc. has 2 FDA actions in our database, including 2 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 (Unilever United States Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Unilever United States Inc. have FDA actions?
Unilever United States Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0211-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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