← FDA ENFORCEMENT
D-0155-2025Class II

Amerisource Health Services LLC

Recalling firm
Amerisource Health Services LLC
Product type
Drug
Status
Ongoing
Report date
2025-01-01
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
21,262 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, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

Code / lot info

Lot DT3023029A Exp 02/28/2025

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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.