D-021-2014 Class I Terminated
FDA drug recall D-021-2014 was initiated by Jack Rabbit, Inc on August 12, 2013 and is designated Class I. 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 pharmaceutica… The recall status is terminated (terminated October 5, 2020). Affected quantity: 1,000 Tablets.
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