Product: Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Reason for recall: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: 20230323
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated