Skip to content
Recall Observatory FDA recall evidence

Drug product

ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles

D-1151-2016

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-1151-2016

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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.