Drug & medication recalls High risk

BodySlim Herbal Advanced technology & Strong formula capsules recalled over undeclared sibutramine

Recall date
December 7, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
BotanicalNow recalls BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
Recall number
D-0471-2018
FDA classification
Class I
Brand / firm
BotanicalNow
Sold / distributed
U.S.A. Nationwide

Why it was recalled

Marketed without an approved NDA/ANDA: FDA analysis found the product to contain 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

BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481

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