D-1145-2016 Class I Terminated
FDA drug recall D-1145-2016 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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US… The recall status is terminated (terminated April 23, 2020).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: 1,104 bottles.
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
- 1,104 bottles
Product Description
Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Distribution Pattern
Nationwide
Code Information
All lots