Drug Enforcement D-0100-2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Product quantity
23,490 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
PA, OH, PR

Location & Firm

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

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

Codes & Dates

Recall number
D-0100-2025
Event ID
95849
Recall initiation date
November 14, 2024
Center classification date
December 3, 2024
Code info
a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
More code info
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