Reported Nov 18, 2015 · Terminated

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve,…

Breckenridge Pharmaceutical, 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: Breckenridge Pharmaceutical, Inc · 15 Massirio Dr Ste 201 · Berlin, CT · 06037-2352

Is this the product you have?

  • Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle
  • Manufactured byLaboratorios Dr. Esteve, S.A., Barcelona, Spain
  • Distributed byBreckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
  • NDC51991-748-10
Lot codes and dates
    • Lot #: 142391
    • Exp 10/2016
Amount recalled
595 Bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

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 Dec 24, 2015 · Data as of Sep 19, 6:28 PM UTC

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