REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Gentamicin Sterility Failure at The Medicine Shoppe Pharmacy Highlights Compounding Risks
The Medicine Shoppe Pharmacy initiated a Class II recall (D-1072-2020) for Gentamicin 80mg/60 mL Irrigation due to lack of sterility assurance. This Florida-centric recall, terminated December 2022, underscores critical quality control vulnerabilities in local pharmaceutical compounding. Procurement and regulatory teams must scrutinize sterility protocols across all suppliers, regardless of scale, to mitigate patient safety risks.
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