Class IIReported 2024-12-11

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

Recalled by Amerisource Health Services LLC

Reason for Recall

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

Recall Number

D-0101-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2024-11-14

Reported

2024-12-11

Distribution

PA, OH, PR

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.