Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories

Recall Number: D-0100-2025

Firm: Amerisource Health Services LLC

Classification: Class II

Status: Ongoing

Report Date: 20241211

Initiation Date: 20241114

Termination Date:

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

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories