Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising...
FDA Recall #D-0105-2025 — Class II — November 19, 2024
Product Description
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recalling Firm
Rising Pharma Holding, Inc. — East Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
209,376 bottles
Distribution
Nationwide.
Code Information
a) Lot # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated