D-0058-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2017
- Initiation Date
- October 6, 2017
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 700 bottles
Product Description
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Distribution Pattern
Nationwide.
Code Information
All lots remaining within expiry.