D-0963-2017 Class I Terminated

Recalled by Organic Herbal Supply — Roseville, CA

Recall Details

Product Type
Drugs
Report Date
July 19, 2017
Initiation Date
April 18, 2017
Termination Date
March 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451

Reason for Recall

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

Distribution Pattern

Nationwide via internet

Code Information

All lots and package sizes