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Recall Observatory FDA recall evidence

Drug product

BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481

D-0471-2018

December 07, 2017

Class I

Product summary

Firm
BotanicalNow
Event
Event 78720
Status
Terminated
Classification
Class I
Quantity
5 bottles
Official record key
drug-enforcement:D-0471-2018

Official wording

Reason: Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.

Code information: MFD: 05.06.2016 EXP: 05.05.2018

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.