Drug & medication recalls High risk

BLACK GOLD X ADVANCED capsules recalled over undeclared sibutramine

Recall date
April 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Making It a Lifestyle recalls BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Recall number
D-0221-2017
FDA classification
Class I
Brand / firm
Making It a Lifestyle
Sold / distributed
Nationwide

Why it was recalled

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.

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

BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.

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