D-0097-2018 Class III Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
December 6, 2017
Initiation Date
November 21, 2017
Termination Date
April 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
111,648 units

Product Description

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 Pattern

Nationwide within the United States

Code Information

Lot #: G602051, Exp. 12/2017