Drug & medication recalls High risk

RHINO 7 Platinum 5000 recalled over undeclared active

Recall date
September 15, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Gadget Island, Inc recalls RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY…
Recall number
D-0103-2018
FDA classification
Class I
Brand / firm
Gadget Island, Inc
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224

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