REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Assurance Infusion's LIPO B Sterility Breach Impacts US Supply Chain
Assurance Infusion initiated a Class II recall (D-0749-2020) for its LIPO B product due to a critical lack of sterility assurance. This Houston, TX-based manufacturer's voluntary action, affecting nationwide U.S. distribution, highlights persistent quality control challenges in specialty pharmaceuticals. The recall, active from December 2019 to October 2021, underscores the imperative for robust supplier qualification and stringent sterility protocols to mitigate supply chain risks.
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