Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutic
Recalled January 1, 2025 · FDA recall D-0162-2025 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. · FDA Class II
Units
76,968 bottles
Sold at
Nationwide in the US
Description
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Manufacturer(s)
Breckenridge Pharmaceutical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →