P&J Trading announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements sold under the brand name Slimdia Revolutionspecific to the following product below. There is no identifying lot number.
Slimdia Revolution (bottles 30 capsules)
P&J Trading is conducting a voluntary recall after being notified by the US FDA that testing found the Slimdia Revolution products, specific to the above lot numbers, contain Sibutramine. Sibutramine is an appetite suppressant that was FDA-approved for the treatment of obesity.
It is Schedule IV controlled substance and because of the risks associated with its use, it should be taken only under the direct supervision of qualified health care professional.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine has been withdrawn from U.S marketplace.
The active drug ingredient is not listed on the label for these products. This product was distributed nationwide in US from March 2012 to December 2012.
P&J Trading advises any customers in possession of the Slimdia Revolution products to return any unused product for a full refund to the company directly. Customers can call 714-726-6544 (9am to 5pm, Monday-Friday) for instructions on the return and refund process.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
Online: http://www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressedform.
Fax: 1800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. P&J Trading is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing.
P&J Trading promises its customers the highest possible quality and welcomes the recall process as future evidence of our commitment to our brands, products and consumers.
