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As a result, the patient subsequently required 25% less levothyroxine to maintain her thyroid hormone levels
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FDA noted in the warning letter that [i]t is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture pesticides or other non-pharmaceutical products due to the risk of cross-contamination. 35 FDA also found that the active ingredient isopropanol was substituted wholly or in part with ethanol and cited the company for inadequate release testing, among other violations
Korczynski W, Ceregrzyn M, Matyjek R, Kato I, Kuwahara A, Wolinski J, Zabielski R
Toxicol Pathol 17, 64250
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