D-0593-2018 Class I Terminated
FDA drug recall D-0593-2018 was initiated by Bella All Natural on February 14, 2018 and is designated Class I. 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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in … The recall status is terminated (terminated January 28, 2019). Affected quantity: 32 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 14, 2018
- Initiation Date
- February 14, 2018
- Termination Date
- January 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 bottles
Product Description
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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.
Distribution Pattern
Product was distributed in California to online customers and retail stores.
Code Information
Lot #: MFD:10.15.2017, Exp.10/14/2019.