FDA-Drug2025-12-10Class IICHEMICAL
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
7389 bottles
Manufactured in
200 Connell Dr Ste 4200, Berkeley Heights, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0216-2026Want us to check the next one for you?
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