FDA-Drug2025-07-16Class II
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Breckenridge Pharmaceutical, Inc.
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Sold states
U.S. Nationwide
Affected count
12,242 30-count bottles
Manufactured in
200 Connell Dr Ste 4200, N/A, Berkeley Heights, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2025Don't want to check this manually?
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