Recalls / Class II

Class IID-0099-2025

Product

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Amerisource Health Services LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188

Distribution

Quantity

37,916 bottles

Distribution pattern

PA, OH, PR

Timeline

Recall initiated

2024-11-14

FDA classified

2024-12-03

Posted by FDA

2024-12-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0099-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.