November 2017 FDA Recall Drug by Byl Solutions Inc.
D-0414-2018 - Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
This Class III drug recall was voluntarily initiated by Byl Solutions Inc. on November 30, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product found to be tainted with sildenafil. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0414-2018
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
11-30-2017
02-21-2018
329 tins
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
BYL Solutions Inc.
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.
Nationwide
05-11-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
Batch or Lot Expiration Information
Lot# All lots remaining within expiry.
