D-021-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 4, 2013
- Initiation Date
- August 12, 2013
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,000 Tablets
Product Description
J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934
Reason for Recall
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.
Distribution Pattern
Nationwide
Code Information
Lot #: 2510 Exp 04/01/15