Posted September 25, 2018

FDA Warns Seller of Digestive Enzyme Supplements

On March 6, 2018, the FDA issued a warning letter to Uckele Health & Nutrition, Inc., following a facility inspection which the company's products, including  Digestzyme Plus, Apexenergetics (K-104) Histo- X 90 CT Caps, BIO-M for Men 120's Nutri GNX, Apexenergetics (K-99) Enzymix Pro and ANS Internal Facelift, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include to failure to establish product specifications for each dietary supplement for the identity and purity of the finished batch of the dietary supplement, as required by federal regulations, and approving and releasing for distribution a dietary supplement containing components that did not meet identity specifications.

See's Review of Digestive Enzyme Supplements Supplements for tests of related products.

See Related Warnings:

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FDA Warns Seller of Milk Thistle, Chromium, Joint Supplements & More for Manufacturing Violations

Seller of Male Enhancement, Prostate Supplements & More Warned for Drug Claims

To read the full warning letter, use the link below: