FDA Recall D-021-2014
Jack Rabbit, Inc · Melbourne, FL
Class I — life-threatening Terminated 2611 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-021-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2013-08-12
- Classified by FDA Center
- 2013-11-27
- FDA published
- 2013-12-04
- Terminated
- 2020-10-05
- Recalling firm
- Jack Rabbit, Inc
- Firm location
- Melbourne, FL