FDA MedWatch - Adam’s Secret Extra Strength 1500 and 3000 Capsules by Adamssecret.co: Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: FDA MedWatch - Adam's Secret Extra Strength 1500 and 3000 Capsules by Adamssecret.co: Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil  AUDIENCE: Consumer, Health Professional, Pharmacy  ISSUE: Adamssecret.co is recalling all lots within expiry of Adam's Secret Extra Strength 1500 and Adam's Secret Extra Strength 3000 capsules after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafil.  To date, adamssecret.co has not received any reports of adverse events related to this recall. Consumers with underlying medical issues who take Adam's Secret Extra Strength 1500 or Adam's Secret Extra Strength 3000 capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, phosphodiesterase (PDE-5) inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. For more information about this recall click on red button "Read Recall" below. BACKGROUND: Sildenafil and tadalafil are ingredients in FDA approved products for the treatment of male erectile dysfunction in the family of drugs known as PDE-5 inhibitors. The presence of sildenafil and/or tadalafil in Adam's Secret Extra Strength products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall. The recalled product is marketed as a dietary supplement for male sexual enhancement. RECOMMENDATIONS:  Consumers that have Adam's Secret Extra Strength 1500 or 3000, which is being recalled should stop using and return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Consumers and health professionals and 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. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA