Class II
Terminated
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
- Company
- Shionogi Inc.
- Recall Initiated
- March 8, 2012
- Posted
- July 4, 2012
- Recall Number
- D-1398-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7230 bottles
- Firm Location
- Alpharetta, GA, United States
Reason for Recall
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Distribution
PA
Lot / Code Info
Lot number: 2021956, Exp; 01/2013
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