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 Pharmac
Recall Summary Duloxetine 60 mg delayed-release capsules in 1,000-capsule bottles manufactured by Towa Pharmaceuticals Europe for Quallient Pharmaceuticals are being recalled nationwide. The capsules contain higher-than-acceptable levels of N-nitroso-duloxetine, a potentially harmful impurity, due to manufacturing process deviations. The recall affects all U.S. states and territories.
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product
- 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.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-24
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/a94b66e2-1990-4aa1-bdab-152a37beb4f6