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Posted February 10, 2015

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

On January 21, 2015, the FDA issued a warning letter to Fragrance Manufacturing Incorporated, following a facility inspection which found the company's products, including Maty's All Natural Cough Syrup and Maty's All Natural Cough Syrup for Kids, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish product specifications for the identity, purity, strength, and composition of finished batches of dietary supplements, and failure to make and keep documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, as required by federal regulations.

In addition, the product names, Maty's All Natural Cough Syrup and Maty's All Natural Cough Syrup for Kids were found to be drug claims because they establish that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Maty's All Natural Cough Syrup and Maty's All Natural Cough Syrup for Kids contain buckwheat honey, cinnamon, zinc, apple cider vinegar, cayenne pepper, sea salt, lemon balm, lemon peel, cloves and marjoram.

See ConsumerLab.com's Review of Zinc Supplements and Lozenges for tests of related products.

See Related Warnings:

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below.