Reported Jul 4, 2012 · Terminated

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH…

Shionogi 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: Shionogi Inc. · 5770 Shiloh Rd · Alpharetta, GA · 30005-8408

Is this the product you have?

  • Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only
  • Manufactured forPrasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France
  • NDC0677-1979-01
Lot codes and dates
  • Lot number
    • 2021956
    • Exp
    • 01/2013
Amount recalled
7230 bottles

Where it was sold

Why it was recalled

Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point

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 Feb 7, 2013 · Data as of Sep 19, 7:02 PM UTC

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