Home / Recalls / Medical Devices
Valeant Pharmacueticals International recalls Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos,
Recalled May 25, 2016 · FDA recall Z-1699-2016 · Valeant Pharmacueticals International
Hazard
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. · FDA Class II
Units
7,716
Sold at
Nationwide Distribution
Description
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.
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.
Manufacturer(s)
Valeant Pharmacueticals International
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →