D-0628-2021 Class II Ongoing
FDA drug recall D-0628-2021 was initiated by DASH XCLUSIVE on May 11, 2021 and is designated Class II. Reason for recall: Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine The recall status is ongoing. Affected quantity: 25 pieces (boxes containing 15 sachets).
Recall Details
- Product Type
- Drugs
- Report Date
- June 23, 2021
- Initiation Date
- May 11, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 pieces (boxes containing 15 sachets)
Product Description
Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Distribution Pattern
Nationwide within the United States
Code Information
All Lots