PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: March 14, 2018 Initiated: February 14, 2018 #D-0593-2018

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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.

Details

Recalling Firm
Bella All Natural
Units Affected
32 bottles
Distribution
Product was distributed in California to online customers and retail stores.
Location
Los Angeles, CA

Frequently Asked Questions

What product was recalled?
Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015. Recalled by Bella All Natural. Units affected: 32 bottles.
Why was this product 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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 14, 2018. Severity: Critical. Recall number: D-0593-2018.