REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Santa Cruz Biotechnology's Subpotent Hand Sanitizer Exposes Potency Control Gaps
Santa Cruz Biotechnology, Inc. faced a Class II FDA recall for 14,238 bottles of UltraCruz Hand Sanitizing Gel due to subpotency. This event, initiated August 7, 2020, and terminated June 14, 2021, highlights critical quality control vulnerabilities in pharmaceutical manufacturing. Procurement and regulatory teams must scrutinize supplier quality agreements and implement robust testing protocols to mitigate similar supply chain risks.
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