FDA recall D-1398-2012

Shionogi Inc. · Class II · 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

Reason for recall

Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point

Distribution

Key facts

Status: Terminated
Initiation date: 2012-03-08
Report date: 2012-07-04
Termination date: 2013-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1398-2012