REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Glenmark's Ranolazine Tablets Impacted by CGMP Deviations, Raising Supply Chain Concerns
Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall (D-0335-2025) for Ranolazine Extended-Release Tablets 1000mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This action, impacting lot 17240040, signals critical quality control deficiencies at the manufacturing site in Pithampur, India. Procurement and regulatory teams must assess supply chain risks and evaluate alternative Ranolazine sources to ensure continuity and compliance.
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