United States
Company name: HIS
Brand name: HIS
Product recalled: Dietary Supplement for Weight Loss
Reason of the recall: Undeclared Sibutramine
FDA Recall date: July 22, 2021
Recall details: Palisades Park, NJ, HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count & 30 count capsules) to the consumer level. HIS decided to recall Miss Slim after it was contacted by the FDA regarding the presence of sibutramine in the product.
Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. The presence of sibutramine in Miss Slim renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. To date, HIS has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement and is packaged 10 count UPC (742137605030) and 30 count UPC (609728434472) capsules. The product sold online at missslimusa.com.
Risk Statement: 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.
HIS is notifying its customers by website missslimusa.com and is arranging for return of all recalled products. Consumers that have Miss Slim which is being recalled should stop using it. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Check the full recall details on
www.fda.gov
Source: FDA
