Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Recall Number: D-0162-2025

Firm: Breckenridge Pharmaceutical, Inc

Classification: Class II

Status: Ongoing

Report Date: 20250101

Initiation Date: 20241206

Termination Date:

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

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.