D-0121-2018 Class I Terminated
FDA drug recall D-0121-2018 was initiated by EZWeightLossTX LLC on July 24, 2017 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs. The recall status is terminated (terminated February 10, 2021). Affected quantity: 4958 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 27, 2017
- Initiation Date
- July 24, 2017
- Termination Date
- February 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4958 bottles
Product Description
LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
Reason for Recall
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Distribution Pattern
Nationwide
Code Information
All lots remaining within expiry.