Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: 20241206
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated