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Recall Observatory FDA recall evidence

Drug product

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

D-1207-2015

December 19, 2014

Class I

Product summary

Firm
Bethel Nutritional Consulting, Inc
Event
Event 70089
Status
Terminated
Classification
Class I
Quantity
UNKNOWN
Official record key
drug-enforcement:D-1207-2015

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.

Code information: Lot # 140430; Exp.12/17

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.