Drug product

BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086

D-0968-2017

April 18, 2017

Class I

Product summary

Firm: Organic Herbal Supply
Event: Event 77055
Status: Terminated
Classification: Class I
Quantity: Unavailable
Official record key: drug-enforcement:D-0968-2017

Official wording

Reason: Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

Code information: All lots and package sizes

Distribution pattern: Nationwide via internet

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin