Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
Product description
iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.
Lot numbers, UPCs & expiration codes
Lot: 0000:02, Exp 06/20/17
Where it was sold
WV who distributed 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-0981-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 25, 2015
- FDA report date
- May 13, 2015
- Quantity
- 200 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Detox Transforms
Original FDA data
Every field from FDA enforcement report D-0981-2015, exactly as published.
Show all FDA fields
- City
- Garner
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 70444
- Address
- 1027 Us Highway 70 W
- Address (line 2)
- Suite 227
- Code information
- Lot: 0000:02, Exp 06/20/17
- Postal code
- 27529-2501
- Report date
- May 13, 2015
- Product type
- Drugs
- Recall number
- D-0981-2015
- Classification
- Class I
- Recalling firm
- Detox Transforms
- Product quantity
- 200 bottles
- Termination date
- Jan 23, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.
- Distribution pattern
- WV who distributed Nationwide.
- Recall initiation date
- Jan 25, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 4, 2015