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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Intercharm Inc. Issues a Correction to the Nationwide Voluntary Recall of Slim Forte Slimming Capsules Lot 20100604 and Lot 20100928, Slim Forte Slimming Coffee Lot 20100903, and Meizitang Botanical Slimming 100% Natural Soft gel Exp. 12.23.2011 Weight Loss Capsules Found to Contain Sibutramine.
FOR IMMEDIATE RELEASE - September 2, 2011 - Intercharm Inc., Fort Lauderdale, Florida, issues a correction to their July 25, 2011 voluntary recall of Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Meizitang Botanical Slimming 100% Natural Soft Gel to the consumer/user level. FDA laboratory analyses found the products to contain Sibutramine an appetite suppressant. Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons. The July 25, 2001 press release stated the Slim Forte Slimming Coffee was distributed in a box containing 10 packets of instant coffee. The product actually contained 12 packets of coffee.
- Slim Forte Slimming Capsules is packaged in a green box with a picture of a woman on the front. The box has pink, blue, and green text. The box contains 30 capsules.
- Slim Forte Slimming Coffee is packaged in a green box with a picture of a woman on the front. The box has pink, blue, and green text. The box contains 12 packets of instant coffee.
- Meizitang Botanical Slimming 100% Natural Soft Gel, 650 mg, is packaged in a green pouch with green background and a picture of a woman on front. The package has yellow, white, and black text. The pouch contains 3 blister packs of 12-count softgel capsules.
Products containing Sibutramine pose a threat to consumers because Sibutramine is known to 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. These products may also interact in life threatening ways with other medications a consumer may be taking. Intercharm Inc. has not received any reports of adverse events related to this recall.
These products are sold as dietary supplements and marketed for weight loss. Slim Forte Slimming Capsule, Batch No. 20100928, Best By 09.27.2012 and Batch No. 20100604, Best By 06.03.2012; Slim Forte Slimming Coffee, Batch No. 20100903, Best By 09.02.2012; and Meizitang Botanical Slimming 100% Natural Soft Gel, Lot Code 12.24.2009, Best By 12.23.2011 are included in this recall. Products were distributed through the internet nationwide and internationally to Ireland.
Consumers should stop using these products immediately and return to the place of purchase. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Any questions related to this recall should be directed to Intercharm Inc. at 323-876-7441 Monday through Friday 8:00 AM to 4:30 PM, EST.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online, by regular mail, or by fax.
- 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.
- Fax: 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.