- Company Announcement Date:
- August 02, 2021
- FDA Publish Date:
- August 02, 2021
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Product contains sibutramine
- Company Name:
- Je Dois L’avoir Boutique
- Brand Name:
- Product Description:
High Intensity Pills and Emergency Boutique
Hanford, California, Je Dois L’avoir Boutique is voluntarily recalling all of the 365 Skinny High Intensity Pills and or 365 Skinny Emergency Boutique, 30 day capsules supply to the retail/consumer level. The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique have been found to contain Sibutramine which is a controlled substance by the DEA and poses significant health risks to consumers both products are from the same manufacturer 365 Skinny is the strongest form and the 365 Skinny Emergency is for people with high blood pressure, diabetes but not limited to other chronic illnesses.
Risk Statement: The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique potentially can cause serious health risks such as seizures, tachycardia, palpitations, heart attacks and allergic reactions. Risks associated with this product are more likely with people who have high blood pressure, thyroid disease, men or woman over 65 or children under 16 years old. Je Dois L’avoir Boutique has not received any reports of adverse events related to this recall.
The product is used together with diet and exercise to assist with weight loss and is packaged in bottles of 30 capsules 600mg per capsule.
All lots and expiration dates of any of these products are being recalled. Je Dois L’avoir is recalling ALL 365 Skinny High Intensity Pills and 365 Emergency Boutique that it has sold to the public as seen below.
Je Dois L’avoir is notifying its distributors and customers by email and is arranging for return/replacement etc. of all recalled products. Consumers that have 365 High Intensity Skinny or 365 Skinny Emergency Boutique which is being recalled should stop using/return to place of purchase/discard/contact Je Dois L’avoir Boutique Immediately at 559-302-6215.
Consumers with questions regarding this recall can contact Je Dois L’avoir Boutique by phone Monday-Friday 9-6pm pacific standard time or email us 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.