November 2016 FDA Recall Drug by Ms Bionic (D-0472-2017 - Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED))

This Class I drug recall was voluntarily initiated by Ms Bionic on November 30, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in fda approved drugs used to treat erectile dysfunction (ed). The product was distributed in CA and the recall is currently terminated.

Recall Number: D-0472-2017

Reason for Recall
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Initiated
11-30-2016
Reported
02-22-2017
Quantity
100 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75753
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.
MS Bionic
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.
CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-01-2017
Product Description About Product Description
Full technical description of the product.
MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA

Batch or Lot Expiration Information

Lot# All Lots exp. date 12/2019