May 2017 FDA Recall Drug by Brian P. Richardson
D-1117-2017 - Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk

This Class I drug recall was voluntarily initiated by Brian P. Richardson on May 25, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; fda analysis result found product to contain sildenafil, tadalafil and undeclared milk. The product was distributed in TX and the recall is currently terminated.

Recall Number: D-1117-2017

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Initiated
05-25-2017
Reported
08-30-2017
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77375
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.
Brian P. Richardson
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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2021
Product Description About Product Description
Full technical description of the product.
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987

Batch or Lot Expiration Information

Lot# all lots within expiry.