Drug & medication recalls High risk

Infinity Capsules recalled over undeclared sibutramine

Recall date
December 15, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Bee Extremely Amazed LLC recalls Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
Recall number
D-1141-2016
FDA classification
Class I
Brand / firm
Bee Extremely Amazed LLC
Sold / distributed
Nationwide

Why it was recalled

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.

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

Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition

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