The U.S. Food and Drug Administration (FDA) just announced that Health and Beyond LLC is recalling some lots of its Tranquility product, which were found to contain two medications: Doxepin, a pharmaceutical for sleep and Chlorpormazine, a drug prescribed for psychotic disorders.
Use of the recalled Tranquility product could potentially cause dizziness and could also cause a public health risk. Health and Beyond LLC stated that it has not received any reports of adverse events related to this recall, to date.
Tranquility is meant to be used as a sleep product and is packaged in a white bottle that contains 30 pills. The impacted lots are numbers 36678 and 36680 and bear a 9/15 expiration date. Tranquility was distributed nationwide and via wholesale, retail, and Internet sales.
Health and Beyond LLC is advising its distributors and customers via personal telephone calls and written recall letters and is also arranging for return and/or replacement of all recalled products. Consumers, distributors, and retailers in possession of the recalled Tranquility product are advised to cease using the product and return the product to the place of purchase.
Health and Beyond LLC may be reached by email at firstname.lastname@example.org. Consumers are also advised to contact their physicians or healthcare providers 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 the recalled Tranquility product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online at www.fda.gov/medwatch/report.htm; by regular mail, use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form; or send by fax at 1-800-FDA-0178.