D-1141-2016 Class I Terminated
FDA drug recall D-1141-2016 was initiated by Bee Extremely Amazed LLC on December 15, 2015 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US… The recall status is terminated (terminated April 23, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 13, 2016
- Initiation Date
- December 15, 2015
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
Reason for Recall
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
Distribution Pattern
Nationwide
Code Information
All lots