December 2015 FDA Recall Drug by Nuway Distributors, Llc
D-0667-2016 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Nuway Distributors, Llc on December 23, 2015 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 ongoing.

Recall Number: D-0667-2016

Reason for Recall
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Initiated
12-23-2015
Reported
02-24-2016
Quantity
100,000 blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73016
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Nuway Distributors, LLC
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.
Product Description About Product Description
Full technical description of the product.
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.

Batch or Lot Expiration Information

Lot# All lots