Multi-event July 2016 FDA Recall Drug by Dream Body Weight Loss
This Multi-event Class II drug recall was voluntarily initiated by Dream Body Weight Loss on July 1, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in United States and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0106-2017
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
07-01-2016
10-26-2016
Unknown
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.
Dream Body Weight Loss
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.
United States
09-30-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
Batch or Lot Expiration Information
Lot# All lots.
Recall Number: D-0108-2017
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
07-01-2016
10-26-2016
Unknown
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.
Dream Body Weight Loss
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.
United States
09-30-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Batch or Lot Expiration Information
Lot# All lots.
Recall Number: D-0107-2017
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
07-01-2016
10-26-2016
Unknown
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.
Dream Body Weight Loss
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.
United States
09-30-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Batch or Lot Expiration Information
Lot# All lots.
