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HIS Issues Voluntary Nationwide Recall of Miss Slim Due to the Presence of Undeclared Sibutramine

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Dietary Supplements

Reason for Announcement:

Recall Reason Description

Undeclared Sibutramine

Company Name:
HIS
Brand Name:

Brand Name(s)

Product Description:

Product Description

Dietary Supplement for Weight Loss


Company Announcement

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Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues.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.

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.

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.

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 with questions regarding this recall can contact HIS by e-mail at [email protected]. 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.

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.

  • Complete and submit the report Online
  • Regular Mail or Fax: 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Media:
Kwang Lee


Product Photos

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Author: FDA

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