FDA-Drug2025-08-13Class II
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Breckenridge Pharmaceutical, Inc.
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Sold states
U.S Nationwide
Affected count
1,829 60-count bottles
Manufactured in
200 Connell Dr Ste 4200, N/A, Berkeley Heights, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0552-2025Don't want to check this manually?
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