United StatesDuloxetine Delayed-Release Capsules, USP, 60 mg in 1,000‑capsule bottles (Rx only) with NDC 82009-032-10 and NDC 51991-748-10 — lots 240947C (Exp 04/2027), 240962C (Exp 04/2027), 240534C (Exp 01/2027) and 240977C (Exp 04/2027) — manufactured by Towa Pharmaceuticals Europe for Quallient and distributed by Breckenridge Pharmaceutical. They were recalled for CGMP deviations due to the presence of N‑nitroso‑duloxetine impurity above the FDA recommended limit; the recall covers units sold nationwide in the United States.
What's being recalled
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.
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.
Recalling firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ, United States.
How to identify it
Lot #: 240947C, 240962C, Exp. Date 04/2027 Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
The hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)