D-1378-2014 Class I Terminated
FDA drug recall D-1378-2014 was initiated by MyNicNaxs, Inc. on January 24, 2014 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine The recall status is terminated (terminated October 2, 2019). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2014
- Initiation Date
- January 24, 2014
- Termination Date
- October 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL
Reason for Recall
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Distribution Pattern
Nationwide
Code Information
ALL LOTS