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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Latest Posted July 25, 2024
West Coast Laboratories Warned for Manufacturing, Labeling Violations
On March 12, 2024, the FDA issued a Warning Letter to West Coast Laboratories, Inc. following an inspection of the company’s facility which found its products including certain calcium, collagen, and chromium ingredients, to be adulterated because they were, packed, labeled or held under conditions that do not meet Current Good Manufacturing Practices (cGMP).
For more information and tests of related products, see Consumer Lab’s Reviews of Calcium and Bone Health Supplements, Collagen Supplements, and Chromium Supplements.
Violations noted by the FDA’s included failure to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use, failure to establish specifications for the purity, strength, and composition of dietary supplement ingredients including at least two ingredients that are components of the company’s CalComplex formula, Naticol HPMG (a branded marine-based collagen ingredient), Aquamin F (a branded plant-based calcium ingredient), as well as other dietary supplement ingredients such as chromium picolinate, and calcium pyruvate.
The FDA also noted that the company’s Calcium Pyruvate, Chromium Picolinate, and Calcium Complex Formula #3 (CalComplex) were misbranded because the product labels fail to provide information required by federal regulations.
West Coast Laboratories, Inc. must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.
For more information, use the link below.
Warning: West Coast Laboratories, Inc.
See related recalls and warnings:
NutraCaps Labs Warned for Unsafe Ingredients and Manufacturing Violations
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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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Other Recent Recalls & Warnings
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please visit the FDA MedWatch website.
