Drug Enforcement D-0105-2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

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Product Information

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
Product quantity
209,376 bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
Rising Pharma Holding, Inc.
Address
2 Tower Center Blvd Ste 1401

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0105-2025
Event ID
95756
Recall initiation date
November 19, 2024
Center classification date
December 5, 2024
Code info
a) Lot # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25
More code info
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