Drug recall
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los…
FDA recall event 73678 · Class II · Valeant Pharmacueticals International
Key facts
| Event ID | 73678 |
|---|---|
| Recall numbers | Z-1699-2016 |
| Recalling firm | Valeant Pharmacueticals International |
| Product type | Devices |
| Products | Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period. |
| Initiation date | Jan 29, 2016 |
| Report date | May 25, 2016 |
| Termination date | Oct 6, 2017 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3009443653 |
At a glance
- 1–9 Products in this recall
- 1–9 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: