September 2014 FDA Recall Drug by Forest Pharmaceuticals Inc
D-0036-2015 - Failed Dissolution Specification; at the 6-month stability time point

This Class II drug recall was voluntarily initiated by Forest Pharmaceuticals Inc on September 26, 2014 for the product Drug. The FDA reported the reason for recall as failed dissolution specification; at the 6-month stability time point. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0036-2015

Reason for Recall
Failed Dissolution Specification; at the 6-month stability time point
Initiated
09-26-2014
Reported
10-29-2014
Quantity
94,584 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69298
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.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07

Batch or Lot Expiration Information

Lot# Lot A369286, exp. date 31 Jan 2016