← FDA ENFORCEMENT
D-0099-2025Class II

Amerisource Health Services LLC

Recalling firm
Amerisource Health Services LLC
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
PA, OH, PR
Firm state
OH
Product quantity
37,916 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06

Code / lot info

Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.