FDA MedWatch - Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

AUDIENCE: Consumer

ISSUE: Regeneca Worldwide, a division of VivaCeuticals, Inc. is conducting a nationwide recall of its entire line of herbal and dietary supplement products pursuant to a Consent Decree entered by the federal court for the Central District of California. This recall applies to all products manufactured and sold between June 1, 2011 and February 8, 2017. These products include, but are not limited to RegeneSlim, RegenErect, RegeneArouse, RegeneBlend, RegeneBoost, RegeneBlast, and RegeneFit. All lot numbers are included in this recall.

BACKGROUND: Regeneca products were sold nationwide online using the company's websites, and through a direct sales force within the United States and Puerto Rico for both consumption and retail sales. The company has presently ceased doing business in the United States.

RECOMMENDATION: Consumers who have purchased Regeneca products subject to this recall are advised to immediately stop using the product and are urged to return it to the place of purchase. Consumers with questions may contact the company via email to support@xxxxxxxxxxxx.

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

Read the MedWatch safety alert, including a link to the press release, at

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm545870.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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