FDA Recall D-0455-2024

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

SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

Lot / code: All lots

Quantity: 7 pieces

Reason for recall

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

Recall record

Recall number: D-0455-2024
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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