MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramSten Z and M1 Alpha Capsules by Andropharm: Recall - Contains Derivatives of Anabolic SteroidsAUDIENCE: 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. 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:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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