Drug 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
D-1398-2012
Product summary
- Firm
- Shionogi Inc.
- Event
- Event 62004
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7230 bottles
- Official record key
drug-enforcement:D-1398-2012
Official wording
Reason: Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Code information: Lot number: 2021956, Exp; 01/2013
Distribution pattern: PA
Derived failure modes
-
Potency or specification failure
Out of Specification