FDA Recall D-0642-2021

NSNY Distributor Inc · Flushing, NY

Class I — life-threatening Ongoing 1862 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

Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3

Lot / code: all lots

Quantity: 399 capsules

Reason for recall

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

Recall record

Recall number: D-0642-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: USA Nationwide
Recall initiated: 2021-04-08
Classified by FDA Center: 2021-06-28
FDA published: 2021-07-07
Recalling firm: NSNY Distributor Inc
Firm location: Flushing, NY

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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