Multi-event August 2013 FDA Recall Drug by Fabscout Entertainment, Inc

This Multi-event Class I drug recall was voluntarily initiated by Fabscout Entertainment, Inc on August 14, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in CA, FL and UT and the recall is currently terminated.

Reported Recall Events

D-377-2014 TERMINATED D-376-2014 TERMINATED D-378-2014 TERMINATED

Recall Number: D-377-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
Initiated
08-14-2013
Reported
12-25-2013
Quantity
578 blister packs of 1 capsule each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66043
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.
Fabscout Entertainment, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, FL and UT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2021
Product Description About Product Description
Full technical description of the product.
72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-376-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Initiated
08-14-2013
Reported
12-25-2013
Quantity
32 bottles of 6 capsules each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66043
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.
Fabscout Entertainment, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, FL and UT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2021
Product Description About Product Description
Full technical description of the product.
Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-378-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Initiated
08-14-2013
Reported
12-25-2013
Quantity
18 blister packs of one capsule each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66043
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.
Fabscout Entertainment, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, FL and UT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2021
Product Description About Product Description
Full technical description of the product.
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC

Batch or Lot Expiration Information

Lot# All Lots