FDAClass IIOctober 29, 2014

Bystolic recall: Failed Dissolution

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

Why was Bystolic recalled?

Failed Dissolution Specification; at the 6-month stability time point

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 A369286, exp. date 31 Jan 2016

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
Recalling firm
Forest Pharmaceuticals Inc
Quantity
94,584 cartons
Distribution
Nationwide including Puerto Rico.
Recall date
October 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls