Recall D-0621-2025
Recalling firm
Breckenridge Pharmaceutical, Inc., NJ
Product
Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10
Reason for recall
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.