Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients
AUDIENCE: Consumer, Health Professional
ISSUE: Jack Rabbit Inc. announced that it is conducting a voluntary nationwide recall of one lot of the company's dietary supplement product sold under the name Jack Rabbit. FDA lab analysis of the product was found to contain Sildenafil and Tadalafil, which are active ingredients of FDA-approved drugs for erectile dysfunction (ED), making Jack Rabbit an unapproved drug. The undeclared ingredients may interact with nitrates found in some prescription drugs such as Nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
BACKGROUND: Jack Rabbit Pack is marketed as a dietary supplement for sexual enhancement. It is packaged in 4 count blister packs and distributed online and retail stores nationwide.
RECOMMENDATION: Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Consumers should return any unused product to the retail location where they were purchased or contact Jack Rabbit, Inc. at JackRabbit4pack.com for a return address.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/12/2013 - Press Release - Jack Rabbit Inc.]