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FDA later published a determination that it was not withdrawn for reasons of safety or effectiveness , but it is no longer commercially available as an FDA-approved product (FDA, 2013)

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This increases the risk that: Products may be contaminated or mislabeled Adverse events may not be monitored or reported Patients may be misled about efficacy 4

Understand renewal requirements: If approved, know when your benefits expire and how to reapply to avoid any gaps in coverage