The FDA announced that Kiriko, LLC is voluntarily recalling all lots of a weight-loss dietary supplement after a laboratory analysis revealed dangerous chemicals and prescription drugs.
The supplement, A1 Slim 30, was tainted with sibutramine, phenolphthalein and N-desmethyl sibutramine. Sibutramine is an appetite suppressant sold under the name Meridia, but was withdrawn from the market in 2010 over safety concerns; N-desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites increase blood pressure and/or heart rate in certain patients, and are dangerous to patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein used to be used in OTC laxatives, but concerns about its carcinogenicity led to its removal from the market in the United States.
A1 Slim 30 is marketed in a white plastic bottle and contains 30 capsules, and has the barcode number A105212014. The recall affects all lots within expiry. The product was distributed in retail stores in Houston and by mail order.
Any adverse reactions involved with the supplement or any other product can be submitted to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178