FDA-Drug2012-07-04Class II
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
Shionogi Inc.
Hazard
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Sold states
PA
Affected count
7230 bottles
Manufactured in
5770 Shiloh Rd, Alpharetta, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1398-2012Don't want to check this manually?
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