Nisoldipine Tablet, Film Coated, Extended Release
FDA Recall NDC 66993-472

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Nisoldipine (NDC 66993-472). A significant event, classified as Class III, was initiated on Jul 24, 2015 by Prasco Laboratories. The reported reason for this action was: "Failed Dissolution Specifications"

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-1284-2015TERMINATED

July 2015 Class III Recall: Failed Dissolution Specifications

Recall Number
D-1284-2015
Class III Terminated
Reason for Recall
Failed Dissolution Specifications
Initiated
Jul 24, 2015
Reported
Aug 12, 2015
Quantity
a) 483 bottles; b) 5,631 bottles

Recall Profile & Regulatory Data

Event ID
71828
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Shionogi Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Apr 14, 2016
Product Description
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.
Batch or Lot Expiration Information
Lot# : a) 8803472, Exp 03/16; b) 8803473, Exp 03/16
Affected Packages Involved in this Recall
66993-472-02Product
66993-473-02Product
66993-475-02Product
59630-501-10Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.