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The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Current Good Manufacturing Practice (CGMP) requirements, ultimately classifying products manufactured at the facility as adulterated under the Federal Food, Drug, and Cosmetic Actnot because contamination was confirmed, but because the quality systems could no longer be relied upon

Do not chew, crush, or split the tablets, as this may damage the tablet structure and affect drug absorption

[DOI] [PubMed] [Google Scholar] Werner H