October 2017 FDA Recall Drug by Kiriko, Llc.
D-0058-2018 - Marketed Without An Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Kiriko, Llc. on October 6, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0058-2018

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.
Initiated
10-06-2017
Reported
11-08-2017
Quantity
700 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78235
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Kiriko, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2020
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.