MedicineWatch US
Class II Recall

Breckenridge Pharmaceutical, Inc.

Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Classification
Class II
Status
Ongoing
Lot
Lot 240539C, Exp 1/31/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Breckenridge Pharmaceutical, Inc. — Class II Recall | MedicineWatch US