PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 8, 2017 Initiated: October 6, 2017 #D-0058-2018

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.

Details

Recalling Firm
Kiriko, LLC.
Units Affected
700 bottles
Distribution
Nationwide.
Location
Manvel, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Kiriko, LLC.. Units affected: 700 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0058-2018.