Recalls & Warnings
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Posted June 6, 2017
Seller of Herbal Supplements Warned for Manufacturing Violations, Drug Claims
These violations include failure to establish specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, failure to establish and follow written procedures for the responsibilities of the quality control operations, and failure to calibrate instruments and controls used in the manufacturing of your dietary supplements, as required by federal regulations.
In addition, statements made about these products on labels and the company's website were found to be drug claims.
For example, Fang Feng Formula was promoted with statements such as "[D]ark and burning urine, skin rashes or infections, boils, carbuncles, hemorrhoids, intestinal bleeding...," Lung Support-Y was promoted with statements such as quot;[B]ronchitis, or pneumonia…"
Other products, such as DHZC-2 Blood Circulation Regulator (Lower Abdomen) tablet, Brain-ECM capsule, TT Side Regulator tablet, and SHT Chest Relief were found to be misbranded, because the labels failed to provide required information, such as the capsule ingredients and/or a full domestic address or domestic phone number.
See Related Warnings:
To read the FDA's warning letter, use the link below