Recalls / Class II

Class IID-0101-2025

Product

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

Affected lot / code info

Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024; Lot DT6023034A, 12/31/2024; Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025; Lots DT6023073A, DT6023072A, exp 02/28/2025

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

8,561 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-0101-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.