MyNicKnaxs, LLC., located in Florida is announcing a recall of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction because these products contain undeclared active pharmaceutical ingredients: Phenolphthalein, sibutramine or a combination of both.
Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. Sibutramine is an appetite suppressant (drug Schedule IV) that was withdrawn from the U.S. market in October 2010 for safety reason (seizure, cardiovascular risks: heart attacks, arrhythmia and strokes among others). These undeclared ingredients makes these products unapproved new drugs for which safety and efficacy have not been established. Consumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
All lots of these products are being recalled.
MyKnicKnaxs, LLC. has taken this voluntary action because it is committed to providing accurate information to all customers and is concerned for the health and safety of all users . MyKnicKnaxs, LLC, is working with the FDA in the recall process. We sincerely regret any inconvenience the recall may cause customers.
Customers are advised to immediately discontinue use and should return the products immediately to the place of purchase. Consumers with questions should contact Chevonne Torres at 386-337-8142 or via e-mail at nicnaxs@yahoo.com Monday - Friday,2:00 am – 7:00 pm, EDT.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to address on the pre-addressed form.
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