Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupi...
FDA Recall #D-0097-2018 — Class III — November 21, 2017
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
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
111,648 units
Distribution
Nationwide within the United States
Code Information
Lot #: G602051, Exp. 12/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated