The FDA released the following:
Palisades Park, NJ, HIS is voluntarily recalling all batches and presentations of Miss Slim (10 capsules and 30 capsules) at the consumer level. HIS has decided to recall Miss Slim after being 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 taken off the market due to safety concerns. The presence of sibutramine in Miss Slim makes it an unapproved drug for which the safety and effectiveness have 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 dramatically increase blood pressure and / or pulse in some patients and may pose a significant risk to patients with a history of coronary heart disease. , stroke.
The product is marketed as a dietary supplement and is packaged in 10-unit UPC (742137605030) and 30-unit UPC (609728434472) capsules. The product sold online on missslimusa.com.
HIS informs its customers by website missslimusa.com and organize the return of all recalled products. Consumers who have recalled Miss Slim should stop using it. Consumers with questions regarding this recall can contact HIS by email at [email protected] Consumers should contact their doctor or health care provider if they have had any problems that may be related to taking or using this medication.
Adverse reactions or quality issues encountered while using this product can be reported to the MedWatch Adverse Event Reporting Program of the FDA, either online, by regular mail, or by fax.
- Complete and submit the report In line
- Regular mail or fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form, or fax it to 1-800-FDA-0178
This recall is being made with the knowledge of the United States Food and Drug Administration.
Suggest a correction