Unlikely to cause harm — often a labeling or packaging issue.
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
| Distributed by / for | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) |
| NDC | 51079-882-20 |
| Full product label | Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20 |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) |
| Distribution | Nationwide |
| Quantity | 46,472 unit dose blister cards (10 cards of 10 tablets each) |
| Recall initiated | 2016-09-28 |
| Report date | 2016-11-16 |
| Recall completed | 2018-08-28 |
| Recall number | D-0136-2017 |
| 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 ↗