Unlikely to cause harm — often a labeling or packaging issue.
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
| Distributed by / for | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) |
| NDC | 51079-881-21 |
| Full product label | 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) |
| Distribution | Nationwide |
| Quantity | 868 unit cartons (86,800 tablets) |
| Recall initiated | 2016-01-28 |
| Report date | 2016-02-10 |
| Recall completed | 2016-12-21 |
| Recall number | D-0650-2016 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Rockford IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗