Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited,
Recalled December 11, 2024 · FDA recall D-0101-2025 · Amerisource Health Services
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit · FDA Class II
Units
8,561 bottles
Sold at
PA, OH, PR
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 bottle, 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 →