Drug product
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.
D-1067-2014
Product summary
- Firm
- Health & Beyond
- Event
- Event 65273
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 bottles
- Official record key
drug-enforcement:D-1067-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Code information: All lots. Expiration date 09/2015.
Distribution pattern: Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)