Product: Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recall initiated: 20241114
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated