FDA-Drug2025-03-19Class II
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Breckenridge Pharmaceutical, Inc.
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Sold states
Nationwide
Affected count
11,125 bottles.
Manufactured in
200 Connell Dr Ste 4200, Berkeley Heights, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0271-2025Don't want to check this manually?
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