Golden State Medical Supply Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottle
Recalled July 3, 2024 · FDA recall D-0568-2024 · Golden State Medical Supply
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. · FDA Class II
Units
21,655 (30 count bottle), 34,149 (90 count bottle)
Sold at
Nationwide in the U.S.
Description
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Product
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Manufacturer(s)
Golden State Medical Supply Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →