A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearl...
FDA Recall #D-0058-2018 — Class II — October 6, 2017
Product Description
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, [email protected] 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.
Recalling Firm
Kiriko, LLC. — Manvel, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
700 bottles
Distribution
Nationwide.
Code Information
All lots remaining within expiry.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated