Recalls / Class II
Class IID-1398-2012
Product
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
- Affected lot / code info
- Lot number: 2021956, Exp; 01/2013
Why it was recalled
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Recalling firm
- Firm
- Shionogi Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5770 Shiloh Rd, Alpharetta, Georgia 30005-8408
Distribution
- Quantity
- 7230 bottles
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2012-03-08
- FDA classified
- 2012-06-26
- Posted by FDA
- 2012-07-04
- Terminated
- 2013-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1398-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.