FDA recall D-0097-2018

Product

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

Reason for recall

Failed Dissolution Specification

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2017-11-21

Report date

2017-12-06

Termination date

2019-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

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