Multi-event April 2016 FDA Recall Drug by Making It A Lifestyle
This Multi-event Class I drug recall was voluntarily initiated by Making It A Lifestyle on April 29, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda - presence of undeclared sibutramine.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0221-2017
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
04-29-2016
12-28-2016
1000 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Making It a Lifestyle
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-30-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Batch or Lot Expiration Information
Lot# All Lots
Recall Number: D-0222-2017
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
04-29-2016
12-28-2016
1000 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Making It a Lifestyle
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-30-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Batch or Lot Expiration Information
Lot# All lots
Recall Number: D-0220-2017
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
04-29-2016
12-28-2016
1000 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Making It a Lifestyle
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-30-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Batch or Lot Expiration Information
Lot# All lots
