Why it was recalled
Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Product description
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.
Lot numbers, UPCs & expiration codes
All lots. Expiration date 09/2015.
Where it was sold
Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.
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-1067-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 46 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Health & Beyond
Original FDA data
Every field from FDA enforcement report D-1067-2014, exactly as published.
Show all FDA fields
- City
- Pompano Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65273
- Address
- 4500 NW 12th Dr
- Address (line 2)
- PO Box #15-554
- Code information
- All lots. Expiration date 09/2015.
- Postal code
- 33064-1116
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1067-2014
- Classification
- Class II
- Recalling firm
- Health & Beyond
- Product quantity
- 46 bottles
- Termination date
- Jul 22, 2019
- Reason for recall
- Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.
- Distribution pattern
- Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.
- Recall initiation date
- May 15, 2013
- Initial firm notification
- Telephone
- Center classification date
- Feb 4, 2014