FDA recall D-0155-2025

Amerisource Health Services LLC · Class II · drug

Product

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2024-12-06
Report date: 2025-01-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2025