Recalls & Warnings
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Posted August 25, 2022
Oregon’s Wild Harvest Warned by FDA for Manufacturing Violations
On July 8, 2022, the FDA issued a warning letter to Oregon’s Wild Harvest, Inc. after inspection of the company’s manufacturing facility found Stress Guard, Aller-Aid, Eyes Love Lutein, TumeriPro, Prostate Health, Kids Tranquil Child, Kids Echinacea Goldenseal, CountToZen, Milk Thistle Elixir, Ashwagandha Gingko, Sleep Better, Hawthorn, Bilberry, Cordyceps, and Black Cohosh to be adulterated because the products were prepared, packed, or held in conditions that do not meet Current Good Manufacturing Practices (cGMP).
The inspection found serious violations including failure to reject product lots after visual examination found allergens or other materials. For example, wheat and rock foreign material were detected in Ashwagandha Root COG, tree nut shell, glass, hard plastic, and rodent feces foreign material were detected in the company’s Bilberry Fruit, glass, a AA battery, and tree nut shell foreign material were detected in your Black Cohosh Root.
According to the FDA, the company also failed to establish specifications for the strength and composition of the dietary ingredients in the formulation of Kids Tranquil Child and Eyes Love Lutein.
The company must respond to the agency within 15 days outlining steps taken to address any violations.
For more information, use the link below.
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