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
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