REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Legacy Pharmaceutical Packaging Faces Scrutiny Over Sertraline CGMP Deviations
Legacy Pharmaceutical Packaging LLC initiated a Class II recall for 161,664 bottles of Sertraline Tablets, USP 100 mg, due to inadequate line clearance and potential product commingling at its Earth City, MO facility. This event highlights critical CGMP compliance risks for contract packagers, directly impacting Cipla USA, Inc. and Wal-Mart's supply chains in California and Arkansas, necessitating immediate risk mitigation by procurement and regulatory teams.
90-Day Activity