FDA Device recall Z-1699-2016
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02 by Valeant Pharmacueticals International, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1699-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-29 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Valeant Pharmacueticals International |
| Distribution | US |
Product
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 cartridge into a second fluid container.
Reason
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.
Identifiers
| code_info | Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.