FDAFDA · Food and drugs·Recall number D-1398-2012
Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
Published July 4, 2012 · Recall initiated: March 8, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shionogi Inc.
- Distributor
- PA
- Lot
- Lot number: 2021956, Exp; 01/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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