Drug Enforcement D-0158-2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Product quantity
1,815 bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A

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

Recall number
D-0158-2025
Event ID
95953
Recall initiation date
December 6, 2024
Center classification date
December 23, 2024
Code info
Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
More code info
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