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Hi Tech Pharmaceuticals Issues Voluntary Recall on Lipodrene w/25mg Ephedra Extract Dietary Supplement Due to the Presence of 1,4-dimethylamylamine (DMAA)

COMPANY ANNOUNCEMENT

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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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:

Recall Reason Description

Presence of 1,4-dimethylamylamine (DMAA)

Company Name:
Hi-Tech Pharmaceuticals. Inc
Brand Name:

Brand Name(s)

Hi-Tech Pharmaceuticals. Inc

Product Description:

Product Description

Lipodrene w/25mg Ephedra Extract Dietary Supplement


Company Announcement

Hi-Tech Pharmaceuticals. Inc. of Norcross, GA is recalling Lot # 001211197, Exp. 12/25 of Lipodrene w/25mg Ephedra Extract Dietary Supplement due to the presence of 1,4-dimethylamylamine (DMAA). The FDA has warned that DMAA is dangerous because it can narrow blood vessels and arteries and cause a corresponding rise in blood pressure or other cardiovascular problems, such as: Shortness of breath, Arrhythmias, Elevated blood pressure, Tightening in the chest, and Heart attack. ( https://www.fda.gov/food/dietary-supplement-products-ingredients/dmaa-products-marketed-dietary-supplements) Hi-Tech Pharmaceuticals, Inc. is conducting a continuing investigation on the problem.

There have been no reported illnesses to date.

The voluntary recall was the result of FDA analysis that showed the presence of 1,4-dimethylamylamine in one lot of Lipodrene. Customers who have purchased Lipodrene Lot # 001211197 are advised to stop using this lot of product immediately and return it to the place of purchase for a full refund. Lipodrene Lot # 001211197 was purchased by and distributed through wholesale and direct sales in the U.S. and Puerto Rico, and through online sales for both personal use and retail sales.

Retailers who have any of these products should remove them from the shelves and return them to Hi-Tech immediately. Wholesalers or distributors should alert their customers to the recall and have them return any product back to the place of purchase or to Hi-Tech Pharmaceuticals. Hi-Tech will immediately replace any returned items with product from a different lot.

If you have any questions about this recall, please contact Hi-Tech Pharmaceuticals Inc, Norcross, GA at toll free 1-888-855-7919 from 9:00am to 5:00 pm EST, or you may email any request to recallcoordinator@hitechpharma.com.

Your assistance is appreciated and necessary to prevent consumer illness.

This recall is being made with the knowledge of the Food and Drug Administration. Adverse reactions/events experienced with the use of any of these products should also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. http://www.fda.gov/medwatch/report.htm


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