FDA-Drug2017-12-06Class III

Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068

Lupin Pharmaceuticals Inc.
Hazard

Failed Dissolution Specification

Sold states
Nationwide within the United States
Affected count
111,648 units
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2018

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