June 2014 FDA Recall Drug by Forest Pharmaceuticals Inc
D-1412-2014 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Forest Pharmaceuticals Inc on June 19, 2014 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-1412-2014

Reason for Recall
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Initiated
06-19-2014
Reported
07-09-2014
Quantity
92,544 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68548
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.
Forest Pharmaceuticals 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 including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-05-2016
Product Description About Product Description
Full technical description of the product.
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.

Batch or Lot Expiration Information

Lot# A308879, Expiry: 09/2015