Drug Enforcement D-0165-2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

Status

Ongoing

Classification

Class II

Report Date

January 1, 2025

Termination Date

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Product Information

Product description
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Product quantity
a) 1,564 cards, b) 799 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 in the US

Location & Firm

Recalling firm
RemedyRepack Inc.
Address
625 Kolter Dr Ste 4

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0165-2025
Event ID
95900
Recall initiation date
December 2, 2024
Center classification date
December 26, 2024
Code info
a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
More code info
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