Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification - Undeclared Drug Ingredient
[Update 07/27/2011] - Intercharm Inc., is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Botanical Slimming Soft Gel to the consumer/user level. 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 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.
- 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 10 packets of instant coffee.
- Meizitang Botanical Slimming Soft Gel is packaged in a green package/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 each 650 mg softgel capsules.
ISSUE: FDA is advising consumers not to purchase or use “Slim Forte Slimming Capsules,” “Slim Forte Slimming Coffee,” and “Botanical Slimming Soft Gel. FDA laboratory analysis confirmed that these products contain sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. These products 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.
BACKGROUND: Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel are products marketed for weight loss, sold on various websites and distributed by InterCharm, Inc. This notification is to inform the public of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.
RECOMMENDATION: Consumers should stop using these products immediately and throw them away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form 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