CLASS II Device recall · Reported 25 May 2016 · FDA Enforcement Report
Orapharma (Onpharma) Onset Mixing Pen recalled
Valeant Pharmacueticals International is recalling Orapharma (Onpharma) Onset Mixing Pen, distributed nationwide in the US. The recall was initiated on 29 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1699-2016
- FDA event ID
- 73678
- Recalling firm
- Valeant Pharmacueticals International, Bridgewater, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2016
- FDA classified
- 19 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 29 Jan 2016 | Recall initiated by company | |
| 19 May 2016 | Classified by FDA | +111 days |
| 25 May 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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