Nisoldipine Extended Release Tablets — Class II drug recall D-1398-2012
Terminated recall by Shionogi Inc., reported 2012-07-04, distributed in PA. Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
| Recall number | D-1398-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shionogi Inc., Alpharetta, GA, United States |
| Recall initiated | 2012-03-08 |
| Classified | 2012-06-26 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2013-02-07 |
| Distributed | PA |
| Quantity | 7,230 bottles |
| Reason classes | specification failure |
| NDC | 00677-1979-01 |
| Lot numbers | 2021956 |
| Expiration dates | 2013-01 |
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
Reason for recall
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1398-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.