May 2013 FDA Recall Drug by Health & Beyond (D-1067-2014 - Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic))

This Class II drug recall was voluntarily initiated by Health & Beyond on May 15, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product found to contain doxepin (an antidepressant) and chlorpromazine (an antipsychotic). The product was distributed in Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania. and the recall is currently terminated.

Recall Number: D-1067-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Initiated
05-15-2013
Reported
02-12-2014
Quantity
46 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65273
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Health & Beyond
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-22-2019
Product Description About Product Description
Full technical description of the product.
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.

Batch or Lot Expiration Information

Lot# All lots. Expiration date 09/2015.