Bella Capsules recalled over undeclared sibutramine

Recall date

February 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bella All Natural recalls Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015

Recall number

D-0593-2018

FDA classification

Class I

Brand / firm

Bella All Natural

Sold / distributed

Product was distributed in California to online customers and retail stores.

Why it was recalled

Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.

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

Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015