FDA MedWatch - Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients

AUDIENCE: Consumer

ISSUE: Dynamic Technical Formulations LLC. is voluntarily recalling all lots of Tri-Ton. This product was sold in 90 count bottles as a dietary supplement and includes all lot number and expiration dates of the product. FDA lab analysis of Tri-Ton was found to contain andarine and ostarine which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances.

Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death

BACKGROUND: This product was sold in 90 count bottles through retailers nationwide. Shipment of this product was from June 2016 to March 2017

RECOMMENDATION: Consumers should stop using the product immediately and throw it away in accordance with your state and local ordinances for disposal of drug products or return the unused portion of product for a refund. Consumers with questions regarding this recall can contact Dynamic Technical Formulations by emailingcustomerservice@dtformulations.com or calling 800-331-6723 from 9:00am to 5:00pm EST.

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.fda.gov/MedWatch/report
• 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

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm559907.htm