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- Recall Enforcement Event ID: 74588
Recall Enforment Report D-0106-2017
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Dream Body Weight Loss, originally initiated on 07-01-2016 for the product Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle The product was recalled due to marketed without an approved nda/anda: undeclared sibutramine.. The product was distributed in United States and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0106-2017 | 07-01-2016 | 10-26-2016 | Class II | Unknown | Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Terminated |
| D-0108-2017 | 07-01-2016 | 10-26-2016 | Class II | Unknown | Dream Body Advanced 400 mg 30 capsules in brown foil packets. | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Terminated |
| D-0107-2017 | 07-01-2016 | 10-26-2016 | Class II | Unknown | Dream Body 450 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Terminated |
Recall Enforcement Report D-0106-2017
- Event ID
- 74588 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0106-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
- Reason For Recall
- Marketed without an approved NDA/ANDA: Undeclared sibutramine. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Unknown Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 10-26-2016
- Recall Initiation Date
- 07-01-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-30-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Dream Body Weight Loss
- Code Info
- All lots. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0108-2017
- Event ID
- 74588 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0108-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Dream Body Advanced 400 mg 30 capsules in brown foil packets.
- Reason For Recall
- Marketed without an approved NDA/ANDA: Undeclared sibutramine. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Unknown Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 10-26-2016
- Recall Initiation Date
- 07-01-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-30-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Dream Body Weight Loss
- Code Info
- All lots. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0107-2017
- Event ID
- 74588 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0107-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Dream Body 450 mg 30 capsules in a plastic screw on top bottle
- Reason For Recall
- Marketed without an approved NDA/ANDA: Undeclared sibutramine. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Unknown Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 10-26-2016
- Recall Initiation Date
- 07-01-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-30-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Dream Body Weight Loss
- Code Info
- All lots. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
