FDA Recall D-0209-2024

TCP HRB ACQUISITON LLC · Westport, CT

Class I — life-threatening Ongoing 1548 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06

Lot / code: All lots, expiry on or before August 2023

Quantity: 5.4 million

Reason for recall

Chemical contamination: Presence of benzene

Recall record

Recall number: D-0209-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the US and Canada
Recall initiated: 2022-02-16
Classified by FDA Center: 2023-12-28
FDA published: 2024-01-03
Recalling firm: TCP HRB ACQUISITON LLC
Firm location: Westport, CT

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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