Drug Enforcement D-0106-2025

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, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Product quantity
122,925 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
—

Codes & Dates

Recall number
D-0106-2025
Event ID
95756
Recall initiation date
November 19, 2024
Center classification date
December 5, 2024
Code info
a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-25
More code info
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