FDAClass IIIFebruary 10, 2016

Clonazepam Tablets recall: Impurity Out of Spec

Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21

Why was Clonazepam Tablets recalled?

Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.

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 # 3063759, Exp.07/16

Product
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Quantity
868 unit cartons (86,800 tablets)
Distribution
Nationwide
Recall date
February 10, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls