Recall D-0157-2025
Recalling firm
Amerisource Health Services LLC, OH
Product
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.