Recall: D-0097-2018

Class III - Minor Violations

Class IIIClassification

2017-11-21Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Failed Dissolution Specification

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.