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 recommended interim limit.
Details
Product
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Recalling company
Rising Pharma Holding, Inc.
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide
Initiated
Dec 30, 2024
FDA report date
Jan 15, 2025
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.