FDA Drug Class II — Moderate

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

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

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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,
Brand
Shionogi Inc.
UPC
Lot number: 2021956, Exp; 01/2013

Units Affected

7230 bottles

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