FDA-Drug2016-02-10Class III

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

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard

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

Sold states
Nationwide
Affected count
868 unit cartons (86,800 tablets)
Manufactured in
1718 Northrock Ct, N/A, Rockford, IL, United States
Products
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0650-2016

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