Breckenridge Pharmaceutical, Inc recall (Cls II)

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