Reported Sep 20, 2017 · Terminated

Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only
  • Manufactured byCadila Healthcare Ltd, Ahmedabad
  • India Distributed byZydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
Lot codes and dates
    • Lot #: Z701133
    • Exp 03/19
Amount recalled
44800 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 6, 2020 · Data as of Sep 19, 7:59 PM UTC

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