July 2017 FDA Recall Drug by Chiavna Saffron Llc
D-1145-2017 - Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil

This Class I drug recall was voluntarily initiated by Chiavna Saffron Llc on July 21, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda;fda analysis found product to be tainted with sildendafil and tadalafil. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1145-2017

Reason for Recall
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Initiated
07-21-2017
Reported
09-20-2017
Quantity
211 bottles; 339 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77812
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.
Chiavna Saffron 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-27-2018
Product Description About Product Description
Full technical description of the product.
Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY

Batch or Lot Expiration Information

Lot# a) RO846356 Exp. 8/28/2020; b) RO246852 Exp. 8/28/2020