Reported Dec 6, 2017 · Terminated

Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals,…

Lupin Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174

Is this the product you have?

  • Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only
  • Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States
  • Manufactured by
    • Lupin Limited Goa 403 722 India
    • NDC 68180-295-06
    • UPC 368180295068
Lot codes and dates
    • Lot #: G602051
    • Exp. 12/2017
Amount recalled
111,648 units

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specification

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 15, 2019 · Data as of Sep 19, 6:31 PM UTC

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