March 2012 FDA Recall Drug by Shionogi Inc.
D-1398-2012 - Failed USP Dissolution Test Requirements

This Class II drug recall was voluntarily initiated by Shionogi Inc. on March 8, 2012 for the product Drug. The FDA reported the reason for recall as failed usp dissolution test requirements. The product was distributed in PA and the recall is currently terminated.

Recall Number: D-1398-2012

Reason for Recall
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Initiated
03-08-2012
Reported
07-04-2012
Quantity
7230 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62004
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-07-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot number: 2021956, Exp; 01/2013