FDA MedWatch – Imperial Extreme 2000 mg by S&B Shopper LLC: Recall –

TOPIC: Imperial Extreme 2000 mg by S&B Shopper LLC: Recall – Due to Presence of Undeclared Sildenafil and Tadalafil

AUDIENCE: Consumer, Health Professional, Risk Manager, Pharmacy

ISSUE: S&B Shopper LLC is recalling all lots of Imperial Extreme 2000 mg capsules because FDA analysis has found this product to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil in Imperial Extreme 2000 mg capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore, subject to recall.

Consumers with underlying medical issues who take Imperial Extreme 2000 mg capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, 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.

To date, S&B Shopper LLC has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Sildenafil and tadalafil are ingredients known as PDE-5 inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

RECOMMENDATIONS: 

• Consumers that have Imperial Extreme 2000 mg which is being recalled should stop using and destroy them.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Health professionals and consumers 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.