Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles
Recalled May 15, 2024 · FDA recall D-0482-2024 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit · FDA Class II
Units
281,554/90 & 1000 count bottles
Sold at
US Nationwide.
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), 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 →