| | MedWatch - The FDA Safety Information and Adverse Event Reporting Program | | | TOPIC: 365 Skinny High Intensity and 365 Skinny Emergency Boutique by Je Dois L'avoir Boutique: Recall - Due to the Presence of Sibutramine AUDIENCE: Consumer, Health Professional ISSUE: Je Dois L'avoir Boutique is recalling all of the 365 Skinny High Intensity and or 365 Skinny Emergency Boutique, 30 day capsules because they have been found to contain sibutramine a controlled substance. The 365 Skinny High Intensity 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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 365 Skinny High Intensity Pills and or 365 Skinny Emergency Boutique are used together with diet and exercise to assist with weight loss. RECOMMENDATIONS: - 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.
- 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.
| | | Health professionals and consumers 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.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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