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
2021956Exp01/2013
- Lot number
- 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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