Why it was recalled
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
Product description
Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
Lot numbers, UPCs & expiration codes
All lots
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-1141-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 15, 2015
- FDA report date
- Jul 13, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bee Extremely Amazed LLC
Original FDA data
Every field from FDA enforcement report D-1141-2016, exactly as published.
Show all FDA fields
- City
- Jewett
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 71187
- Address
- 85205 Sportsmans Club Rd
- Code information
- All lots
- Postal code
- 43986-9794
- Report date
- Jul 13, 2016
- Product type
- Drugs
- Recall number
- D-1141-2016
- Classification
- Class I
- Recalling firm
- Bee Extremely Amazed LLC
- Termination date
- Apr 23, 2020
- Reason for recall
- Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 15, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 6, 2016