May 2021 FDA Recall Drug by Dash Xclusive
D-0628-2021 - Marketed without an approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Dash Xclusive on May 11, 2021 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0628-2021

Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Initiated
05-11-2021
Reported
06-23-2021
Quantity
25 pieces (boxes containing 15 sachets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87923
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
DASH XCLUSIVE
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg

Batch or Lot Expiration Information

Lot# All Lots