July 2015 FDA Recall Nisoldipine by Shionogi Inc.
D-1284-2015 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Shionogi Inc. on July 24, 2015 for the product Nisoldipine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1284-2015

Reason for Recall
Failed Dissolution Specifications
Initiated
07-24-2015
Reported
08-12-2015
Quantity
a) 483 bottles; b) 5,631 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71828
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Shionogi Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-14-2016
Product Description About Product Description
Full technical description of the product.
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

66993-472-02 Nisoldipine
66993-473-02 Nisoldipine
66993-475-02 Nisoldipine