PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 6, 2017 Initiated: November 21, 2017 #D-0097-2018

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

Details

Units Affected
111,648 units
Distribution
Nationwide within the United States
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 111,648 units.
Why was this product recalled?
Failed Dissolution Specification
Which agency issued this recall?
This recall was issued by the FDA Drug on December 6, 2017. Severity: Low. Recall number: D-0097-2018.