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COMPANY ANNOUNCEMENT

Advocare Issues Allergy Alert in Select Bottles of Muscle Strength and Nighttime Recovery Product Because of Undeclared Milk Allergen on The Label

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Advocare Issues Allergy Alert in Select Bottles of Muscle Strength and Nighttime Recovery Product Because of Undeclared Milk Allergen on The Label

Summary

Company Announcement Date:
April 06, 2018
FDA Publish Date:
April 06, 2018
Product Type:
Food & Beverages
Allergens
Food & Beverage Safety
Reason for Announcement:
Recall Reason Description
Undeclared milk
Company Name:
Advocare International
Brand Name:
Brand Name(s)
Advocare
Product Description:
Product Description
Muscle Strength and Nighttime Recovery dietary supplements

Company Announcement

AdvoCare International has commenced a voluntary recall of two lots of Muscle Strength and four lots of Nighttime Recovery dietary supplements because they may contain undeclared milk that can elicit an allergic reaction in individuals who are sensitive to milk and milk products.

Individuals who are highly sensitive to milk protein who consumed caplets from these lots may experience symptoms common to a milk allergy including gastrointestinal issues or allergenic skin reactions. Even in those instances involving more intense reactions, any anticipated effects are expected to resolve quickly and typically do not require medical treatment.

Product was distributed nationwide through AdvoCare and our Independent Distributors. Affected product includes 15,640 units of Muscle Strength, Product code: P3221 with lot numbers: 7063341, 7082161, and sold between November 15, 2017 - March 29, 2018 and 48,176 units of Nighttime Recovery, Product code: P3201 lot numbers: 7081841, 7063321, 7052411, 7090471, sold between December 15, 2017 - March 28, 2018.

No reports of adverse events due to a milk allergen had been reported prior to the recall.

As part of a routine formula review, a prospective manufacturer indicated the presence of milk in Ashwagandha, a raw ingredient common to both Muscle Strength and Nighttime Recovery. After AdvoCare was alerted to the possibility of trace amounts of milk in both products, we immediately conducted an investigation and engaged a third-party health hazard evaluation. The investigation concluded that Ashwagandha was extracted using milk. Therefore, trace amounts of milk can be detected in these specific lots. The risk of a mild or severe adverse reaction exists but is extremely low (i.e., less than 0.5% of the adult population). AdvoCare suspended sales of Nighttime Recovery and Muscle Strength while issuing the voluntary recall. Communications were sent to all Distributors and Customers who purchased the affected product through the AdvoCare website. Distributors were instructed to contact any customer to whom they sold the product in-person using the sample email communication.

If you purchased any of the affected product, AdvoCare is urging consumers to call Customer Service at 1-800- 542-4800 from 8 a.m. to 8 p.m. Mon - Fri for a full refund or exchange of the product.


Company Contact Information

Consumers:
1-800-542-4800
Media:
Lindsay Bomar
972-665-4141
lbomar@advocare.com

Product Photos