Drug & medication recalls High risk

FIFTY SHADES 6000 capsule 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 FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 40…
Recall number
D-0105-2018
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

FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056

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