The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Reason
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Classification
Class II
Status
Terminated
Lot
Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Class II Recall | MedicineWatch US