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, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
UNAPPROVED DRUGSNationwide distribution
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Sold states
Nationwide within the United States
Affected count
3397 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, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2026More Breckenridge Pharmaceutical, Inc. recalls
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