Recall - DTF Sexual Chocolate (Chocolate) produced by Nalpac - Undeclared Sildenafil and Tadalafil

Summary

Company Announcement

FOR IMMEDIATE RELEASE - Date - Ferndale, Michigan. Nalpac is voluntarily recalling DTF Sexual Chocolate it purchased and resold. The products have been found to contain sildenafil and tadalafil. Nalpac is not the manufacturer of this product.

Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restricted to use under the supervision of a licensed health care professional. These undeclared ingredients could interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels for those individuals who use prescriptions drugs which contain nitrates. Nalpac has not received any reports of adverse events related to this recall.

The recalled product is packaged in cases containing 20 retail units. The product can be identified by UPC 757817783069 on the product label. The product was available for purchase in adult retail stores and through shopsexology.com and royalsins.com. Please find the product label below:

Nalpac is not the Manufacturer of these products but is voluntarily recalling the product, notifying its customers by email and is arranging for return of all recalled products. Consumers and retailers that have the recalled product should stop using or selling products and return to the place of purchase or discard immediately.

Consumers with questions regarding this recall can contact Nalpac by telephone at 248-541-1140 or by email at [email protected] Monday to Friday from 8:00 am to 4:30 pm eastern. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report:
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.