PlainRecordsFDA · Drug recall
Nisoldipine Extended Release Tablets…
- Date
- July 4, 2012
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Shionogi Inc.
- 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
- Distribution pattern
- PA
- Quantity
- 7230 bottles
- Codes and lots
- Lot number: 2021956, Exp; 01/2013
- Recall started
- March 8, 2012
- Recall number
- D-1398-2012
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-1398-2012. The agency record governs; check it and the company before acting.