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Recall Observatory FDA recall evidence

Drug product

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

D-0100-2025

November 14, 2024

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 95849
Status
Ongoing
Classification
Class II
Quantity
23,490 bottles
Official record key
drug-enforcement:D-0100-2025

Official wording

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

Code information: a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025

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