Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lot #: 2510 Exp 04/01/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-021-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 12, 2013
- FDA report date
- Dec 4, 2013
- Quantity
- 1,000 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jack Rabbit, Inc
Original FDA data
Every field from FDA enforcement report D-021-2014, exactly as published.
Show all FDA fields
- City
- Melbourne
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65895
- Address
- 4355 Dow Rd
- Address (line 2)
- D19
- Code information
- Lot #: 2510 Exp 04/01/15
- Postal code
- 32934-9220
- Report date
- Dec 4, 2013
- Product type
- Drugs
- Recall number
- D-021-2014
- Classification
- Class I
- Recalling firm
- Jack Rabbit, Inc
- Product quantity
- 1,000 Tablets
- Termination date
- Oct 5, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 12, 2013
- Initial firm notification
- Center classification date
- Nov 27, 2013