Status
Terminated
Drug Enforcement D-021-2014
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.
Classification
Class I
Report Date
December 4, 2013
Termination Date
October 5, 2020
Product Information
- 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
- Product quantity
- 1,000 Tablets
- 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 initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Jack Rabbit, Inc
- Address
-
4355 Dow Rd, D19
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-021-2014
- Event ID
- 65895
- Recall initiation date
- August 12, 2013
- Center classification date
- November 27, 2013
- Code info
- Lot #: 2510 Exp 04/01/15
- More code info
- —