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.
UNDECLARED INGREDIENTSNationwide distribution
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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-0216-2026More Breckenridge Pharmaceutical, Inc. recalls
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