FDA MedWatch - Sten Z and M1 Alpha Capsules by Andropharm: Recall - Contains Derivatives of Anabolic Steroids

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sten Z and M1 Alpha Capsules by Andropharm: Recall - Contains Derivatives of Anabolic Steroids

AUDIENCE: Consumer

ISSUE:  Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.

Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or enlarged breasts and shrinkage of the testes in men. Patients with underlying cardiac, hepatic, or prostate conditions may be at higher risk for adverse reactions than otherwise healthy users. To date, Andropharm has not received any reports of these or any illnesses or injuries related to Sten Z or M1 Alpha.

BACKGROUND: Sten Z and M1 Alpha capsules are marketed as dietary supplements and promoted to increase, sustain, and strengthen muscularity. The two products were packaged as capsules in 60 count bottles with the UPC code-642125502948(Sten Z) and UPC code-642125502924(M1 Alpha) and were sold through retailers nationwide in the United States from March 2016 to April 2017. This recall applies to all lot numbers and expiration dates of these products.

RECOMMENDATION: Consumers who have purchased Sten Z and M1 Alpha products should discontinue their use and either return them to their place of purchase or discard the products in accordance with state and local ordinances for disposal of the drug products.

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.

See MedWatch Safety Alert: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm566712.htm