Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Auro...
FDA Recall #D-0099-2025 — Class II — November 14, 2024
Product Description
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 for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
37,916 bottles
Distribution
PA, OH, PR
Code Information
Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated