August 2021 FDA Recall Drug by Phe Inc
D-0819-2021 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Phe Inc on August 18, 2021 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0819-2021

Reason for Recall
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Initiated
08-18-2021
Reported
09-29-2021
Quantity
15000 packets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88530
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Phe 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

Batch or Lot Expiration Information

Lot# All lots, Exp. 12/2025