FDA recall D-0101-2025

Amerisource Health Services LLC · Class II · drug

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

Reason for recall

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

Distribution

PA, OH, PR

Key facts

Status: Ongoing
Initiation date: 2024-11-14
Report date: 2024-12-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0101-2025