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Recall Observatory FDA recall evidence

Drug product

Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle

D-0223-2017

October 28, 2016

Class I

Product summary

Firm
Love My Tru Body
Event
Event 75537
Status
Terminated
Classification
Class I
Quantity
74 bottles
Official record key
drug-enforcement:D-0223-2017

Official wording

Reason: Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.

Code information: Bottles stamped MFD: 03.07.2016 EXP: 03.06.2018

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.