REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Park Avenue Compounding's Phenylephrine HCI Due to CGMP Deviations
Park Avenue Compounding initiated a Class II recall for 858 syringes of Phenylephrine HCI from its Saint Louis, MO facility, citing CGMP deviations. This event underscores critical supply chain vulnerabilities and the imperative for robust quality assurance in pharmaceutical procurement. Decision-makers must reassess supplier qualification and compliance monitoring to mitigate similar regulatory risks.
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