Breckenridge Pharmaceutical, Inc. recall (Cls II)

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing