Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-4
Recalled December 11, 2024 · FDA recall D-0100-2025 · Amerisource Health Services
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit · FDA Class II
Units
23,490 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, 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
Manufacturer(s)
Amerisource Health Services LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →