FDAClass IIMay 28, 2014

Bystolic recall: Failed Dissolution

Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica…

Why was Bystolic recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: A287945, Exp: 08/2015

Product
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica…
Recalling firm
Forest Pharmaceuticals Inc
Quantity
21,875 bottles
Distribution
Nationwide and Puerto Rico
Recall date
May 28, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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