FDA report on product recall from Leiter’s compounding pharmacy due to concerns of sterility assurance

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Intravenous products: FDA report “Leiter’s Compounding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter’s Compounding Pharmacy’s independent testing laboratory. FDA investigators observed that methods used by the independent laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. The FDA has concerns that results obtained from the laboratory are not reliable.”

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