Recalls / Class II

Class IID-0158-2025

Product

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

Affected lot / code info

Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025

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

1,815 bottles

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-12-06

FDA classified

2024-12-23

Posted by FDA

2025-01-01

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0158-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.