PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 10, 2016 Initiated: January 28, 2016 #D-0650-2016

Product Description

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

Reason for Recall

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

Details

Units Affected
868 unit cartons (86,800 tablets)
Distribution
Nationwide
Location
Rockford, IL

Frequently Asked Questions

What product was recalled?
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 868 unit cartons (86,800 tablets).
Why was this product recalled?
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 10, 2016. Severity: Low. Recall number: D-0650-2016.