Class II Recall

Breckenridge Pharmaceutical, Inc.

Product
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Reason
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Classification
Class II
Status
Ongoing
Lot
Lot: 241069C, Exp 05/31/2027
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.