REGULATORY INTELLIGENCE·Recall
FDA Class III Recall: Orient Pharma's Pitavastatin Tablets Fail Impurity Specifications, Impacting Teva Supply
Orient Pharma Co., Ltd. faces an FDA Class III recall for Pitavastatin Tablets due to failed impurity/degradation specifications. This voluntary, firm-initiated action impacts 57,504 bottles manufactured for Teva Pharmaceuticals, distributed in New Jersey. Procurement and regulatory teams must assess immediate supply chain disruptions and re-evaluate supplier quality oversight for Pitavastatin Calcium.
90-Day Activity
Orient Pharma Co.,Pitavastatin Calcium
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2025-07-09