Drug recall
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc…
FDA recall event 73170 · Class III · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Key facts
| Event ID | 73170 |
|---|---|
| Recall numbers | D-0650-2016 |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) |
| Product type | Drugs |
| Products | Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint. |
| Initiation date | Jan 28, 2016 |
| Report date | Feb 10, 2016 |
| Termination date | Dec 21, 2016 |
| City | Rockford |
| State | IL |
| Country | United States |
| FEI number | 1419886 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: