November 2017 FDA Recall Drug by Www.blankterrmall.com
D-0470-2018 - Marketed without an approved NDA/ANDA
This Class I drug recall was voluntarily initiated by Www.blankterrmall.com on November 19, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Product was distributed in the United States. and the recall is currently terminated.
Recall Number: D-0470-2018
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
11-19-2017
01-31-2018
10 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.
www.blankterrmall.com
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed in the United States.
12-11-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
Batch or Lot Expiration Information
Lot# All lots within expiry.
