Recall D-0161-2025

US Class II Ongoing · initiated 2024-12-06

Recalling firm

Breckenridge Pharmaceutical, Inc, CT

Product

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Reason for recall

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

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