Key Takeaway

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, by Shionogi Inc. was recalled on March 8, 2012. The hazard: Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point

FDA Drug Class II Terminated

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,

Recalled: March 8, 2012 ~7230 bottles units affected D-1398-2012

Description

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 / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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,

Drugs

Company Information

Shionogi Inc.

Alpharetta, GA, United States

View all 5 recalls by Shionogi Inc. →

Distribution

PA

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Frequently Asked Questions

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