Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited
Recalled January 1, 2025 · FDA recall D-0158-2025 · Amerisource Health Services
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. · FDA Class II
Units
1,815 bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Manufacturer(s)
Amerisource Health Services LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →