April 2015 FDA Recall Drug by Valeant Pharmaceuticals North America Llc
D-1116-2015 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Valeant Pharmaceuticals North America Llc on April 17, 2015 for the product Drug. 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-1116-2015

Reason for Recall
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Initiated
04-17-2015
Reported
06-17-2015
Quantity
93,237 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71328
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.
Valeant Pharmaceuticals North America LLC
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.
United States Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-12-2016
Product Description About Product Description
Full technical description of the product.
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

Batch or Lot Expiration Information

Lot# : 1309T27; Expiry: 8/15
Lot# : 1309T28, Expiry: 8/15
Lot# : 1311T33, Expiry: 10/15
Lot# : 1311T34, Expiry: 10/15
Lot# : 1312T40, Expiry: 11/15
Lot# : 1312T41, Expiry: 11/15
Lot# : 1403T23, Expiry: 02/16
Lot# : 1403T21, Expiry: 02/16
Lot# : 1405T21, Expiry: 04/16
Lot# :1405T22, Expiry: 04/16.