Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurob...
FDA Recall #D-0157-2025 — Class II — December 6, 2024
Product Description
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.
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
20,734 30-count bottles
Distribution
Nationwide in the USA
Code Information
Lot DT6023061B Exp 01/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated