Drug & medication recalls High risk

Smart Lipo Dietary Supplement capsules recalled over undeclared sibutramine

Recall date
June 3, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Centro Naturista recalls Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arli…
Recall number
D-0878-2016
FDA classification
Class I
Brand / firm
Centro Naturista
Sold / distributed
Nationwide

Why it was recalled

Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

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

Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

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