Recall -- Firm Press Release
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Health and Beyond LLC Issues Voluntary Nationwide Recall of Tranquility Product Due to Product Having Traces of Pharmaceutical Ingredients
Health and Beyond LLC
FOR IMMEDIATE RELEASE - August 7, 2013 – Boca Raton, FL, 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.
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 following expiration date 9/15.
The product was distributed Nationwide, wholesale, retail and via internet.
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 if you choose.
Consumers with questions regarding this recall can contact Health and Beyond LLC via the e-mail address firstname.lastname@example.org on days of the week 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.
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.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available
at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Photo: Product Labels
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.