FDA Drug recall D-1398-2012
Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured b…
- FDA Drug
- Class II
- terminated
- Published 2012-07-04
On 2012-07-04 the FDA classified a Class II recall of Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured b… by Shionogi, citing failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1398-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-08 |
| Published | 2012-07-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Shionogi |
| Distribution | PA |
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
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Identifiers
| code_info | Lot number: 2021956, Exp; 01/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1398-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.