Bystolic Tablet
FDA Recall NDC 0456-1402
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bystolic (NDC 0456-1402). A significant event, classified as Class II, was initiated on May 12, 2014 by Allergan, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
May 12, 2014
May 28, 2014
21,875 bottles
Recall Profile & Regulatory Data
Event ID
68246
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Forest Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jan 05, 2016
Product Description
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30
Batch or Lot Expiration Information
Lot# Lot: A287945, Exp: 08/2015
Affected Packages Involved in this Recall
0456-1402-30Product
0456-1402-90Product
0456-1402-01Product
0456-1402-63Product
0456-1405-30Product
0456-1405-90Product
0456-1405-01Product
0456-1405-63Product
0456-1410-30Product
0456-1410-90Product
0456-1410-01Product
0456-1410-63Product
0456-1420-30Product
0456-1420-90Product
0456-1420-01Product
0456-1420-63Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
