drugs Class II Updated 2012-07-04

Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17mg, 100 count bottle

Recalled 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

Hazard / Issue

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

Issued by

FDA

Affected States: PA
Lot/Code Info: Lot number: 2021956, Exp; 01/2013
View official government recall

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