FDA Recall D-0593-2018
Bella All Natural · Los Angeles, CA
Class I — life-threatening Terminated 348 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
Reason for recall
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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.
Recall record
- Recall number
D-0593-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed in California to online customers and retail stores.
- Recall initiated
- 2018-02-14
- Classified by FDA Center
- 2018-03-13
- FDA published
- 2018-03-14
- Terminated
- 2019-01-28
- Recalling firm
- Bella All Natural
- Firm location
- Los Angeles, CA