Drug product

SUPER HERBS 350 mg, 30 capsules per bottle.

D-0909-2016

November 23, 2015

Class I

Product summary

Firm: Super Herbs
Event: Event 73361
Status: Terminated
Classification: Class I
Quantity: 9 bottles
Official record key: drug-enforcement:D-0909-2016

Official wording

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

Code information: All lots

Distribution pattern: 9 consignees - only 9 bottles distributed

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/or phenolphthalein.