D-1067-2014 Class II Terminated
FDA drug recall D-1067-2014 was initiated by Health & Beyond on May 15, 2013 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic) The recall status is terminated (terminated July 22, 2019). Affected quantity: 46 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2014
- Initiation Date
- May 15, 2013
- Termination Date
- July 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 bottles
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.
Reason for Recall
Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Distribution Pattern
Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.
Code Information
All lots. Expiration date 09/2015.