Reported May 25, 2016 · Terminated
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos,…
Valeant Pharmacueticals International
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Valeant Pharmacueticals International · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867
Is this the product you have?
- 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.
- Lot codes and dates
- Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757
- Amount recalled
- 7,716
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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