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Recall Observatory FDA recall evidence

Drug product

SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition

D-1147-2016

December 15, 2015

Class I

Product summary

Firm
Bee Extremely Amazed LLC
Event
Event 71187
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-1147-2016

Official wording

Reason: Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.