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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted June 30, 2022
FDA Warns Seller of Vision and Allergy Supplements
On May 26, 2022, the FDA issued a warning letter to Golden Lab LLC following an inspection of the website, which found statements about the company’s DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule products to be drug claims.
For example, the company’s website promoted DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule with statements such as, “For those with genetic predisposition to AMD [Age-Related Macular Degeneration]…or lightly-colored eyes should vigorously protect themselves from the risks associated with screen addiction and blue light. Meso Plus Astaxanthin contains the essential nutrients necessary.” Alereve Seasonal Allergy Ocular Support Capsule was promoted for “symptoms associated with ocular allergies and sinus pressure,” and “Without the Side Effects of Antihistamines.”
Inspection of the company’s manufacturing facility also found products to be adulterated because they were held in conditions that do not meet Current Good Manufacturing Practice (cGMP) for dietary supplements. These violations included failure to ensure the purity, strength, and composition of products as well as incomplete documentation relating to the production and control of product batches.
The company has 15 days to respond to the FDA in writing to explain the specific steps taken to address any violations.
See ConsumerLab’s Astaxanthin Supplements Review and Vision Supplements Review for tests of related products.
Also see ConsumerLab’s answer to the question: Which supplements are best for seasonal allergies?
For more information, use the link below.
Warning Letter: Golden Lab LLC
See related recalls and warnings:
Seller of Vision Supplements Warned by FDA
Seller of Omega-3, Ginkgo, Vision Supplements & More Warned for Drug Claims
Seller of Sexual Enhancement, Cholesterol, Resveratrol Supplements and More Warned For Drug Claims
Seller of Astaxanthin, Cinnamon, Pine Bark and More Warned for Manufacturing Violations
Allergy Bee Nasal Swabs Recalled Due to Potential Contamination With Yeast, Mold & Bacteria
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
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Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
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