FDA recall D-1067-2014

Health & Beyond · Class II · 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.

Reason for recall

Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)

Distribution

Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.

Key facts

Status
Terminated
Initiation date
2013-05-15
Report date
2014-02-12
Termination date
2019-07-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pompano Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1067-2014