Class II Recall

Amerisource Health Services LLC

Product
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Classification
Class II
Status
Ongoing
Lot
Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.