Drug product

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

D-0101-2025

November 14, 2024

Class II

Product summary

Firm: Amerisource Health Services LLC
Event: Event 95849
Status: Ongoing
Classification: Class II
Quantity: 8,561 bottles
Official record key: drug-enforcement:D-0101-2025

Official wording

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

Code information: Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024; Lot DT6023034A, 12/31/2024; Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025; Lots DT6023073A, DT6023072A, exp 02/28/2025

Distribution pattern: PA, OH, PR

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-nitroso-duloxetine impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations