Jack Rabbit Herbal Supplement Recalled for Undeclared Prescription Ingredients
Jack Rabbit, Inc. is recalling its J.R. Jack Rabbit All Natural Herbal Supplement because FDA testing found undeclared sildenafil and tadalafil.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Jack Rabbit, Inc. is recalling 1,000 tablets of J.R. Jack Rabbit All Natural Herbal Supplement. The product is marketed as a male enhancement supplement with a lot number of 2510 and an expiration date of 04/01/15. It was distributed nationwide.
The recall was initiated because laboratory analysis conducted by the FDA determined that the product contains two undeclared active pharmaceutical ingredients: sildenafil and tadalafil. These ingredients are typically found in prescription medications for erectile dysfunction. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who purchased this product should stop using it immediately. The presence of undeclared prescription ingredients poses a risk to consumers, particularly those with heart conditions or those taking other medications that may interact with sildenafil or tadalafil.
The recalled product
- 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
- Manufacturer
- Jack Rabbit, Inc
- Category
- Drug — Herbal Supplement
- Affected units
- 1,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 2510 Exp 04/01/15
Distribution
Distributed nationwide across the United States.
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