Drug product
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
D-0058-2018
Product summary
- Firm
- Kiriko, LLC.
- Event
- Event 78235
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 bottles
- Official record key
drug-enforcement:D-0058-2018
Official wording
Reason: 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.
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
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.