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Unable to Compel Recall, FDA Asks Doctors Not to Use NuVision’s Products

This article was originally published in The Gold Sheet

Executive Summary

Dallas compounding pharmacy brushes off FDA’s concerns about sterility assurance despite complaints about one injectable drug product and results of the agency’s inspection. While NuVision asserts compliance with USP requirements, FDA warns physicians that the injectables NuVision compounds may not be sterile.

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