January 2019 FDA Recall Drug by Happy Together, Inc.
D-0388-2019 - Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

This Class I drug recall was voluntarily initiated by Happy Together, Inc. on January 8, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; fda analysis found product to be tainted with undeclared sildenafil and tadalafil. The product was distributed in Product was sold over the internet and the recall is currently terminated.

Recall Number: D-0388-2019

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Initiated
01-08-2019
Reported
01-30-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81913
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Happy Together, Inc.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was sold over the internet
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-26-2021
Product Description About Product Description
Full technical description of the product.
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644

Batch or Lot Expiration Information

Lot# All lots within expiry