Multi-event October 2013 FDA Recall Drug by B @ B Trade Inc.
This Multi-event Class I drug recall was voluntarily initiated by B @ B Trade Inc. on October 7, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product found to contain undeclared sibutramine. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1233-2014
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
10-07-2013
04-23-2014
10 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.
B @ B Trade Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-02-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
Batch or Lot Expiration Information
Lot# ALL LOTS
Recall Number: D-1232-2014
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
10-07-2013
04-23-2014
10 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.
B @ B Trade Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-02-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
Batch or Lot Expiration Information
Lot# ALL LOTS
Recall Number: D-1231-2014
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
10-07-2013
04-23-2014
10 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.
B @ B Trade Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-02-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.
Batch or Lot Expiration Information
Lot# ALL LOTS
