Multi-event May 2014 FDA Recall Drug by Eugene Oregon, Inc.

This Multi-event Class I drug recall was voluntarily initiated by Eugene Oregon, Inc. on May 5, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC and the recall is currently terminated.

Reported Recall Events

D-1614-2014 TERMINATED D-1613-2014 TERMINATED D1612-2014 TERMINATED

Recall Number: D-1614-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Initiated
05-05-2014
Reported
10-08-2014
Quantity
57 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68218
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.
Eugene Oregon, Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-01-2015
Product Description About Product Description
Full technical description of the product.
MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-1613-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Initiated
05-05-2014
Reported
10-08-2014
Quantity
136 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68218
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.
Eugene Oregon, Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-01-2015
Product Description About Product Description
Full technical description of the product.
Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D1612-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Initiated
05-05-2014
Reported
10-08-2014
Quantity
460 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68218
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.
Eugene Oregon, Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-01-2015
Product Description About Product Description
Full technical description of the product.
AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.

Batch or Lot Expiration Information

Lot# All lots