Duloxetine Delayed-Release Capsules recall — Class II (D-0100-2025) · pharmaranks
Class IIOngoing
Duloxetine Delayed-Release Capsules recall
FDA recall D-0100-2025 · initiated Nov 14, 2024
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Details
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Recalling company
Amerisource Health Services LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
PA, OH, PR
Initiated
Nov 14, 2024
FDA report date
Dec 11, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.