Reported May 8, 2013 · Terminated

Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd,…

Jubilant Cadista Pharmaceuticals 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: Jubilant Cadista Pharmaceuticals Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249

Is this the product you have?

  • Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Lot codes and dates
  • Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Amount recalled
12770 bottles

Where it was sold

  • Nationwide

Why it was recalled

cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.

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 Dec 23, 2013 · Data as of Sep 19, 7:10 PM UTC

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