A1 Slim by Kiriko: Recall - undeclared drug ingredients
FDA Oct 27, 2017
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Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns.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.
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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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Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns.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.
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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