Tranquility by Health and Beyond, LLC: Recall - Undeclared Drug Ingredient
ISSUE: Health and Beyond LLC is voluntarily recalling quantity lots of product Tranquility. The products have been found to contain a trace of Doxepin which is a pharmaceutical for sleep and Chlorpormazine for psychotic disorders. The product potentially could result in dizziness and cause public health risk. Health and Beyond LLC has not received any reports of adverse events related to this recall.
BACKGROUND: The product is used as a sleep product and is packaged in a white bottle with 30 pills per bottle with lot #36678 and 36680. The affected product in the Tranquility lots include the expiration date 9/15. The product was distributed Nationwide, wholesale, retail and via internet.
RECOMMENDATION: Health and Beyond LLC is notifying its distributors and customers by personal phone call and written recall letter and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return product to place of purchase.
Consumers with questions regarding this recall can contact Health and Beyond LLC via the e-mail address email@example.com from Monday-Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Healthcare professionals and patients 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: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[08/07/2013 - Press Release - Health and Beyond LLC]
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