Data Composite

Recall D-0101-2025

US Class II Ongoing · initiated 2024-11-14

Recalling firm

Amerisource Health Services LLC, OH

Product

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, 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

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