FDA-Drug2025-02-05Class II
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Sold states
Nationwide within the United States
Affected count
a) 6408 boxes and b)1488 boxes
Manufactured in
341 Mason Rd, La Vergne, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0212-2025Don't want to check this manually?
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