Class II Recall

Breckenridge Pharmaceutical, Inc.

Product
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Classification
Class II
Status
Ongoing
Lot
Lot: 241180C, Exp. Date April 2027.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.