A1 Slim by Kiriko : Recall - Undeclared Drug Ingredients

From Drugs.com - October 6, 2017

A1 Slim by Kiriko : Recall - Undeclared Drug Ingredients

Audience: Consumer

[Posted 10/06/2017]

ISSUE: Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.

These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established; therefore, subject to recall.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.Phenolphthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S.

BACKGROUND: This tainted product is marketed as a weight loss dietary supplement and is packaged in a white plastic bottle containing 30 capsules with a white screw-on cap, barcode A105212014. The recall includes all lots of A1 Slim remaining within expiry. The product was distributed Nationwide via retail stores in Houston, TX and by mail-order (December 6, 2016-May 1, 2017).

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