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FDASeptember 15, 2017drug

grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

What to do

FDA enforcement status: Terminated

Brands named

gadget islandgadget

UPCs

640793555440

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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