D-0471-2018 Class I Terminated
FDA drug recall D-0471-2018 was initiated by BotanicalNow on December 7, 2017 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine. The recall status is terminated (terminated September 25, 2020). Affected quantity: 5 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 31, 2018
- Initiation Date
- December 7, 2017
- Termination Date
- September 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 bottles
Product Description
BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Distribution Pattern
U.S.A. Nationwide
Code Information
MFD: 05.06.2016 EXP: 05.05.2018