April 2019 FDA Recall Drug by Select Distributions Llc
D-1344-2019 - Marketed without an approved NDA/ANDA
This Class I drug recall was voluntarily initiated by Select Distributions Llc on April 9, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in MI, OH and the recall is currently terminated.
Recall Number: D-1344-2019
Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
04-09-2019
06-19-2019
60 boxes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SELECT DISTRIBUTIONS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
MI, OH
10-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
Batch or Lot Expiration Information
Lot# All lots
