Why it was recalled
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Product description
XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
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-1149-2016
- 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-1149-2016, 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-1149-2016
- 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 fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
- 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