August 2021 FDA Recall Drug by Ebay Seller - John Nguyen
D-0797-2021 - Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
This Class I drug recall was voluntarily initiated by Ebay Seller - John Nguyen on August 11, 2021 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.
Recall Number: D-0797-2021
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
08-11-2021
09-22-2021
35 boxes
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.
Ebay Seller - John Nguyen
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.
USA Nationwide
10-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Batch or Lot Expiration Information
Lot# All lots within expiry.
