FDA Recall D-0457-2024

Pyramids Wholesale Inc. · Los Angeles, CA

Class I — life-threatening Ongoing 786 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

ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L

Lot / code: All lots

Quantity: 4,351 pieces

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Recall record

Recall number: D-0457-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA
Recall initiated: 2024-03-19
Classified by FDA Center: 2024-04-22
FDA published: 2024-05-01
Recalling firm: Pyramids Wholesale Inc.
Firm location: Los Angeles, CA

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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