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Recall Observatory FDA recall evidence

Drug product

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

D-0593-2018

February 14, 2018

Class I

Product summary

Firm
Bella All Natural
Event
Event 79327
Status
Terminated
Classification
Class I
Quantity
32 bottles
Official record key
drug-enforcement:D-0593-2018

Official wording

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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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

Code information: Lot #: MFD:10.15.2017, Exp.10/14/2019.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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